Stylet, Tracheal Tube
FDA product code BSR · Class I (low risk) · 21 CFR 868.5790 · Anesthesiology
32510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Scientific Sales Intl., Inc. 3
- Augustine Medical, Inc. 3
- Laerdal Medical Corp. 2
- Polamedco, Inc. 2
- Ackrad Laboratories 2
- Stebar Instrument Corp. 2
- Pivic Promedco 1
- Cook, Inc. 1
- Coast Medical Corp. 1
- Fiberoptic Medical Products, Inc. 1
- Aaron Medical, Inc. 1
- Opticon Medical, Inc. 1
- Laerdal California, Inc. 1
- Eastmed Enterprises, Inc. 1
- Medical Products Div. P.O.L.A. Plasti 1
- Medical Devices, Inc. 1
- Bivona Medical Technologies 1
- Sims Surgical, Inc. 1
- Concept, Inc. 1
- Sheridan Catheter Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional | Cook Incorporated | 08/11/2017SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | Laerdal Medical Corp. | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | Laerdal Medical Corp. | 05/09/1996SE |
| K943104 | Molloy Intubating StyletteBSR · Traditional | Molloy Corp. | 04/18/1996SE |
| K955238 | Rusch Schroeder Endotracheal Tube StyleBSR · Traditional | Rusch Intl. | 02/06/1996SE |
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | Scientific Sales Intl., Inc. | 08/25/1995SE |
| K952100 | Rusch Endotracheal Tube StyletBSR · Traditional | Rusch, Inc. | 08/08/1995SE |
| K952266 | Schroeder Oral/Nasal Directional StyletteBSR · Traditional | Stebar Instrument Corp. | 06/12/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | Polamedco, Inc. | 05/17/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | Polamedco, Inc. | 02/10/1995SE |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | Coast Medical, Inc. | 12/21/1994SE |
| K940799 | FlexguideBSR · Traditional | Scientific Sales Intl., Inc. | 08/18/1994SE |
| K933598 | Endostar(Tm) StyletBSR · Traditional | Fiberoptic Medical Products, Inc. | 01/25/1994SE |
| K935797 | Schroeder Oral/Nasal Directional StyletteBSR · Traditional | Stebar Instrument Corp. | 01/12/1994SE |
| K932081 | Lighted Intubation SyletBSR · Traditional | Aaron Medical, Inc. | 07/27/1993SE |
| K904999 | Weingarten TM Capnographic Intubation StyletteBSR · Traditional | Opticon Medical, Inc. | 01/26/1993SE |
| K922842 | Stylet and Tracheal Lightwand (STL)BSR · Traditional | Laerdal California, Inc. | 12/18/1992SE |
| K921128 | Endotracheal Tube StyletBSR · Traditional | Eastmed Enterprises, Inc. | 06/02/1992SE |
| K914965 | Disposable Stylette with End CapBSR · Traditional | Pivic Promedco | 05/27/1992SE |
| K920468 | Augustine StyletBSR · Traditional | Augustine Medical, Inc. | 04/23/1992SE |
| K912690 | Augustine Guide(Tm) KitBSR · Traditional | Augustine Medical, Inc. | 09/04/1991SE |
| K910659 | Augustine StyletBSR · Traditional | Augustine Medical, Inc. | 05/17/1991SE |
| K905133 | Stylet Trachael TubeBSR · Traditional | Medical Devices, Inc. | 04/22/1991SE |
| K905052 | Bivona Endotracheal Tube StyletBSR · Traditional | Bivona Medical Technologies | 04/02/1991SE |
| K902180 | Tracheal Tube StyletBSR · Traditional | Sims Surgical, Inc. | 07/19/1990SE |
| K865108 | N-Doguide(Tm) Endotracheal Tube Introducing GuideBSR · Traditional | Ackrad Laboratories | 02/10/1987SE |
| K844557 | Ackrad Endotracheal Tube Introducing GuideBSR · Traditional | Ackrad Laboratories | 12/17/1984SE |
| K843490 | Tube-StatBSR · Traditional | Concept, Inc. | 10/04/1984SE |
| K832773 | Sheri-I-Slip Intubating StyletBSR · Traditional | Sheridan Catheter Corp. | 09/12/1983SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | Scientific Sales Intl., Inc. | 10/23/1980SE |
| K772046 | Intubation Procedure KitBSR · Traditional | American Hospital Supply Corp. | 11/23/1977SE |
| K770374 | Stylette, Slick, Cat. No. 2000BBSR · Traditional | Medical Products Div. P.O.L.A. Plasti | 03/30/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0529-2025 Class II | smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The… | Smiths Medical ASD, Inc. | 10/28/2024Open, Classified |
| Z-0528-2025 Class II | smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF…Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The… | Smiths Medical ASD, Inc. | 10/28/2024Open, Classified |
| Z-0527-2025 Class II | smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17…Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The… | Smiths Medical ASD, Inc. | 10/28/2024Open, Classified |
| Z-2587-2017 Class II | Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured…Product size listed on the labeling is incorrect. | Teleflex Medical | 05/11/2017Open, Classified |
| Z-0067-2017 Class II | The Introes Pocket Bougie is an endotracheal tube introducer. The device is an…The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during… | Brathwaites Oliver Medical | 08/19/2016Terminated |
| Z-0246-2016 Class II | Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Teleflex Medical | 08/24/2015Terminated |
| Z-0245-2016 Class II | Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only…Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Teleflex Medical | 08/24/2015Terminated |
| Z-1557-2015 Class II | Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation…Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and… | Vital Signs Colorado Inc. | 03/13/2015Terminated |
| Z-1556-2015 Class II | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to…Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and… | Vital Signs Colorado Inc. | 03/13/2015Terminated |
| Z-1054-2015 Class II | Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to…A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the… | Cardinal Health | 12/23/2014Terminated |
| Z-0517-2012 | Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers:…Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were… | Teleflex Medical | 12/02/2011Terminated |
| Z-2456-2008 | Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc.…Light protector may detach from lighted stylet during intubation. | Vital Signs Colorado Inc. | 08/11/2008Terminated |
| Z-2455-2008 | Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc…Light protector may detach from lighted stylet during intubation. | Vital Signs Colorado Inc. | 08/11/2008Terminated |
| Z-2454-2008 | Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado…Light protector may detach from lighted stylet during intubation. | Vital Signs Colorado Inc. | 08/11/2008Terminated |