Laryngoscope, Rigid
FDA product code CCW · Class I (low risk) · 21 CFR 868.5540 · Anesthesiology
64510(k) clearances
0PMA approvals
52recalls
Manufacturers
- Eastmed Enterprises, Inc. 5
- Augustine Medical, Inc. 5
- Minrad, Inc. 3
- Wilson Greatbatch Technologies, Inc. 2
- Michael S. Upsher 2
- Effner and Spreine Co. 1
- Michigan Instruments, Inc. 1
- Effner, Inc. 1
- Venner Medical (Singapore) Pte, Ltd. 1
- Lothar Scharras 1
- Truphatek, Ltd. 1
- Pilling Co. 1
- Olympus Corp. 1
- Life Support Devices Co. 1
- Medical Instruments and Lamps 1
- Armstrong Ind., Inc. 1
- North American Medical Products, Inc. 1
- Medovations, Inc. 1
- Geller & Bozeman 1
- W.E. Leder Enterprises, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191602 | APA Oxy BladeCCW · Traditional | Venner Medical (Singapore) Pte, Ltd. | 08/02/2019SE |
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)CCW · Traditional | Girgis Scope, LLC | 06/22/2017SE |
| K140951 | Yeescope LaryngoscopesCCW · Traditional | Yeescope Pty. , Ltd. | 11/10/2014SE |
| K121378 | Airtraq SP Airtraq AvantCCW · Traditional | Prodol Meditec , Ltd. | 06/21/2012SE |
| K063477 | Novamed MRI Conditional Laryngoscope SetCCW · Traditional | Novamed, LLC | 02/09/2007SE |
| K062523 | Tru-Mr Laryngoscope SetCCW · Traditional | Truphatek International, Ltd. | 11/17/2006SE |
| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | Minrad, Inc. | 08/31/2006SE |
| K062230 | MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002CCW · Special | Minrad, Inc. | 08/31/2006SE |
| K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional | Minrad, Inc. | 11/15/2004SE |
| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
| K971377 | Greatbatch Scientific MR Compatible LaryngoscopeCCW · Traditional | Wilson Greatbatch Technologies, Inc. | 04/30/1998SE |
| K970619 | Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope HandleCCW · Traditional | Wilson Greatbatch Technologies, Inc. | 11/19/1997SE |
| K945590 | Scopetex(Tm)CCW · Traditional | Smith Helms Mulliss & Moore, L.L.P. | 05/20/1997SE |
| K961832 | Blue Ridge Products Laryngoscope Blade CoverCCW · Traditional | Blue Ridge Medical, Inc. | 09/06/1996SE |
| K945301 | Laryngoscope CoverCCW · Traditional | Sotiria Mourkidou, M.D. | 05/31/1996SE |
| K954787 | IlluminatorCCW · Traditional | Hospitak, Inc. | 01/31/1996SE |
| K954446 | Augustine Intubation GuideCCW · Traditional | Augustine Medical, Inc. | 12/29/1995SE |
| K954438 | Sunmed's Greenline Fiber Optic LaryngoscopeCCW · Traditional | Rms Div. | 12/29/1995SE |
| K953179 | CLM LaryngoscopeCCW · Traditional | Penlon , Ltd. | 10/06/1995SE |
| K951147 | Leigh Med. Tech. Laryngoscope Blade CoverCCW · Traditional | Leigh Med Tech, Inc. | 06/08/1995SE |
| K951804 | Karl Storz Subglottiscope, Neonate and Infant, Fiber Optic Light Carrier, Suction TubeCCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/05/1995SE |
| K945425 | Mcintosh, Miller, Foregger BabyCCW · Traditional | Rudolf Riester GmbH & Co. KG | 03/20/1995SE |
| K945901 | Direct View 2001 FiberlightCCW · Traditional | Mercury Medical | 12/27/1994SE |
| K944428 | Lite-BladeCCW · Traditional | Eare Consulting Service | 11/15/1994SE |
| K945269 | Optus LaryngoscopesCCW · Traditional | Optus, Inc. | 11/07/1994SE |
| K944686 | Fiberoptic Laryngoscope HandleCCW · Traditional | Fiberoptic Medical Products, Inc. | 11/04/1994SE |
| K941319 | The Wuscope SystemCCW · Traditional | Achi Corp. | 10/04/1994SE |
| K930804 | FilliscopeCCW · Traditional | Filliscope, Inc. | 10/07/1993SE |
| K921263 | Sunlite LaryngoscopeCCW · Traditional | Sunmed, Inc. | 06/01/1993SE |
| K926158 | Slater SleeveCCW · Traditional | Tadco, Inc. | 03/19/1993SE |
| K922019 | Laryngoscope RigidCCW · Traditional | Eastmed Enterprises, Inc. | 01/26/1993SE |
| K922275 | Upsherscope(Tm)CCW · Traditional | Upsher Laryngoscope Co. | 01/06/1993SE |
| K915161 | Augustine Fiberoptic LaryngoscopeCCW · Traditional | Augustine Medical, Inc. | 05/29/1992SE |
| K921166 | Augustine Guide KitCCW · Traditional | Augustine Medical, Inc. | 04/23/1992SE |
| K905273 | Bauman Disposable Laryngoscope BladesCCW · Traditional | Vital Signs, Inc. | 03/24/1992SE |
| K915804 | Propper Laryngoscope Blades W Fiber Optic Illum.CCW · Traditional | Propper Mfg. Co., Inc. | 03/20/1992SE |
| K914741 | Amer Profile Miller Laryngoscope Blades, ModifiedCCW · Traditional | Eastmed Enterprises, Inc. | 02/03/1992SE |
| K914168 | Augustine Guide Kit with Gauze SpongeCCW · Traditional | Augustine Medical, Inc. | 10/07/1991SE |
| K912905 | LaryngoscopeCCW · Traditional | Acorn Group, Inc. | 09/30/1991SE |
| K904918 | Belscope LaryngoscopeCCW · Traditional | Avulunga Pty. , Ltd. | 07/22/1991SE |
| K901164 | Neustein LaryngoscopeCCW · Traditional | Neutech Corp. | 10/09/1990SE |
| K901680 | Bauman Rigid LaryngoscopeCCW · Traditional | Palex Intl. SA | 07/12/1990SE |
| K901489 | Macintosh Laryngoscope Blades (American Profile)CCW · Traditional | Eastmed Enterprises, Inc. | 04/10/1990SE |
| K895954 | Laryngostat Laryngoscope HandleCCW · Traditional | Michigan Instruments, Inc. | 10/30/1989SE |
| K883830 | Fiber Optic LaryngoscopeCCW · Traditional | Effner, Inc. | 10/25/1988SE |
| K883819 | Bullard Intubating Laryngoscope Lar-A & Lar-PCCW · Traditional | Circon Acmi | 10/17/1988SE |
| K884073 | Laryngoscope Blade (Robertshaw Style)CCW · Traditional | Eastmed Enterprises, Inc. | 10/13/1988SE |
| K883296 | LaryngoscopeCCW · Traditional | Lothar Scharras | 10/13/1988SE |
| K882433 | Laryngoscope RigidCCW · Traditional | Eastmed Enterprises, Inc. | 09/02/1988SE |
| K883414 | Laryngoscope BladesCCW · Traditional | Truphatek, Ltd. | 08/19/1988SE |
| K882930 | Laser Laryngoscope Dedo Articula. & Feder Dedo ExCCW · Traditional | Pilling Co. | 08/16/1988SE |
| K882659 | Augustine Intubation Guide(Tm)CCW · Traditional | Augustine Medical, Inc. | 07/21/1988SE |
| K872480 | Kahn-Tact U.S.A., Eff LaryngoscopeCCW · Traditional | Effner and Spreine Co. | 08/10/1987SE |
| K861026 | Liban IntubatorCCW · Traditional | Life Support Devices Co. | 07/28/1986SE |
| K844776 | Effner-Saling Laryngoscope for New-BornCCW · Traditional | Medical Instruments and Lamps | 10/01/1985SE |
| K851705 | LaryngoscopeCCW · Traditional | Armstrong Ind., Inc. | 05/21/1985SE |
| K841778 | D.L. Scope Blade & HandleCCW · Traditional | North American Medical Products, Inc. | 05/23/1984SE |
| K833055 | Laryngoscope Blades/Handles & LampsCCW · Traditional | Medovations, Inc. | 11/14/1983SE |
| K832984 | Disposa-Lite Laryngoscope BladeCCW · Traditional | Michael S. Upsher | 10/28/1983SE |
| K833133 | Disposblade LaryngoscopeCCW · Traditional | Geller & Bozeman | 10/27/1983SE |
| K831981 | LaryngescopeCCW · Traditional | W.E. Leder Enterprises, Inc. | 09/29/1983SE |
| K832650 | Upsher Fiberbrite LaryngoscopeCCW · Traditional | Michael S. Upsher | 09/12/1983SE |
| K830047 | Fiber Optic Laryngoscopes W/BatteryCCW · Traditional | Welch Allyn, Inc. | 01/18/1983SE |
| K801452 | Orotracheal Intubation EndoscopeCCW · Traditional | Olympus Corp. | 07/14/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2187-2025 Class I | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2186-2025 Class I | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2185-2025 Class I | Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2184-2025 Class I | BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2183-2025 Class I | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U…Laryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2182-2025 Class I | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1)…Laryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2102-2025 Class I | i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is…Potential for faulty devices as a result of depleted batteries. | Intersurgical Inc | 06/17/2025Open, Classified |
| Z-2717-2024 Class II | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyIFU update to address device's battery handling information. | Covidien | 07/09/2024Open, Classified |
| Z-2637-2024 Class I | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result… | Covidien | 07/09/2024Open, Classified |
| Z-2636-2024 Class I | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result… | Covidien | 07/09/2024Open, Classified |
| Z-2022-2024 Class II | Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software…Due to software issues, their is the potential for loss of image or a degradation of the image when using… | Verathon, Inc. | 04/29/2024Open, Classified |
| Z-2021-2024 Class II | Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product…Due to software issues, their is the potential for loss of image or a degradation of the image when using… | Verathon, Inc. | 04/29/2024Open, Classified |
| Z-0575-2024 Class II | Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF:…The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | Karl Storz Endoscopy | 10/24/2023Open, Classified |
| Z-0144-2024 Class I | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000Defective video laryngoscopes that did not pass quality tests established for the product, that were… | Covidien | 09/28/2023Open, Classified |
| Z-0169-2024 Class II | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx OnlyLaryngoscope blades may contain an ineffective application of anti-fog agent which may result in… | Covidien | 08/10/2023Open, Classified |
| Z-0168-2024 Class II | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx OnlyLaryngoscope blades may contain an ineffective application of anti-fog agent which may result in… | Covidien | 08/10/2023Open, Classified |
| Z-1288-2022 Class II | #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LEDPackaging error. | Baxter Healthcare Corporation | 05/17/2022Terminated |
| Z-2172-2021 Class III | GlideScope Go MonitorsHandheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor… | Verathon, Inc. | 07/01/2021Open, Classified |
| Z-1294-2021 Class II | RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of…Teleflex is voluntarily recalling the products referenced above due to customers reporting that the… | Teleflex Medical Inc | 02/18/2021Open, Classified |
| Z-2732-2020 Class II | Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2731-2020 Class II | Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2730-2020 Class II | Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2729-2020 Class II | Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2728-2020 Class II | Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2727-2020 Class II | Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage:…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2726-2020 Class II | Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The…Breaking at the point of a welded joint | Teleflex Medical Inc | 07/06/2020Terminated |
| Z-2476-2020 Class I | GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope…When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or… | Verathon, Inc. | 06/05/2020Terminated |
| Z-1408-2020 Class II | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope…Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may… | Medtronic, PLC | 01/28/2020Open, Classified |
| Z-1117-2020 Class II | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemThe products are being recalled due to reports of breakage broke at the point of a welded joint either prior… | Teleflex Medical Inc | 01/09/2020Terminated |
| Z-1116-2020 Class II | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemThe products are being recalled due to reports of breakage broke at the point of a welded joint either prior… | Teleflex Medical Inc | 01/09/2020Terminated |
| Z-0802-2020 Class II | BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF…The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope… | Flexicare Medical Ltd. | 11/27/2019Terminated |
| Z-0801-2020 Class II | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF…The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope… | Flexicare Medical Ltd. | 11/27/2019Terminated |
| Z-0916-2020 Class I | King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a…Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the… | King Systems Corp. dba Ambu, Inc. | 11/05/2019Terminated |
| Z-1471-2020 Class II | GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level… | Verathon, Inc. | 03/31/2019Terminated |
| Z-3238-2017 Class II | BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an…Potential for intermittent lighting (flickering) during use. | Bomimed | 07/13/2017Terminated |
| Z-1852-2017 Class II | It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part…Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device… | Verathon Inc | 03/03/2017Terminated |
| Z-0705-2018 Class II | Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing… | Teleflex Medical | 01/10/2017Terminated |
| Z-1035-2016 Class I | GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope…The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when… | Verathon, Inc. | 01/29/2016Terminated |
| Z-0421-2016 Class II | GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116…Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to… | Verathon, Inc. | 11/30/2015Terminated |
| Z-0420-2016 Class II | GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001…Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to… | Verathon, Inc. | 11/30/2015Terminated |
| Z-0811-2016 Class II | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The…Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility… | Verathon, Inc. | 04/13/2015Terminated |
| Z-0494-2015 Class II | McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each…The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming… | Aircraft Medical Limited | 11/04/2014Terminated |
| Z-2119-2014 Class II | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a…Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct… | Teleflex Medical | 07/09/2014Terminated |
| Z-2130-2014 Class II | RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile…There is a possibility the handle of the laryngoscope may heat up and melt the end cap. | Teleflex Medical | 06/30/2014Terminated |
| Z-0366-2014 Class II | Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway…Labeling inconsistency | Teleflex Medical | 10/15/2013Terminated |
| Z-1558-2013 Class I | GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable…Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature… | Verathon, Inc. | 05/08/2013Terminated |
| Z-0478-2013 Class I | The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a…Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential… | Verathon, Inc. | 10/25/2012Terminated |
| Z-1221-2012 | Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and…Disposable laryngoscope blades incorrectly labeled with wrong size. | Penlon, Ltd. | 09/21/2011Terminated |
| Z-3213-2011 | Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647…Disposable laryngoscope blades incorrectly labeled with wrong size. | Penlon, Ltd. (Fmly East Healthcare) | 03/10/2011Terminated |
| Z-1024-2011 | Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs…Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination. | Vital Signs Colorado Inc. | 12/20/2010Terminated |