Airways (Guedel, Berman & Nasopharyngeal Types)
FDA 510(k) K890342 · Eastmed Enterprises, Inc.
510(k) numberK890342
Submission
- Device name
- Airways (Guedel, Berman & Nasopharyngeal Types)
- Applicant
- Eastmed Enterprises, Inc.
Marlton, NJ, US - Received
- January 23, 1989
- Decision date
- April 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTO – Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5800
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…BTO · Special | Vitaltec Corporation | 09/11/2026SE |
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…BTO · Traditional | Vitaltec Corporation | 06/10/2025SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | Teleflex Medical | 03/22/2024SE |
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube)…BTO · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/22/2020SE |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated…BTO · Traditional | Smiths Medical Ads, Inc. | 04/10/2018SE |
| K120079 | Primed Tracheostomy Tubes (Multiple)BTO · Traditional | Primed Halberstadt Medizintechnik GmbH | 05/24/2012SE |
| K101721 | Well Lead Tracheostomy Tube and Disposable Inner CannulaBTO · Special | Regulatory and Marketing Services, Inc. | 03/24/2011SE |
| K100950 | Venner Pneux P.Y. (TM) Tracheostomy TubeBTO · Traditional | Venner Medical (Singapore) Pte, Ltd. | 07/13/2010SE |
| K100480 | Rota-Trach Tracheostomy Tube Model Rota-TrachBTO · Traditional | Vitaltec Corporation | 06/11/2010SE |
| K100283 | Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…BTO · Traditional | Cook, Inc. | 04/23/2010SE |
More from Cook, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922019 | Laryngoscope RigidCCW · Traditional | 01/26/1993SE |
| K921128 | Endotracheal Tube StyletBSR · Traditional | 06/02/1992SE |
| K914741 | Amer Profile Miller Laryngoscope Blades, ModifiedCCW · Traditional | 02/03/1992SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 01/08/1991SE |
| K901489 | Macintosh Laryngoscope Blades (American Profile)CCW · Traditional | 04/10/1990SE |
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | 11/14/1988SE |
| K884073 | Laryngoscope Blade (Robertshaw Style)CCW · Traditional | 10/13/1988SE |
| K884072 | 15 Millimeter Male and Female AdaptersCAI · Traditional | 10/07/1988SE |
| K882433 | Laryngoscope RigidCCW · Traditional | 09/02/1988SE |
| K882434 | Mask, Gas, AnestheticBSJ · Traditional | 06/30/1988SE |
Questions and answers
When was Airways (Guedel, Berman & Nasopharyngeal Types) cleared by the FDA?
Airways (Guedel, Berman & Nasopharyngeal Types) (K890342) received a 510(k) decision of Substantially Equivalent on April 27, 1989, 94 days after the submission was received.
What is the product code of K890342?
The FDA product code is BTO – Tube, Tracheostomy (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5800.