Linder Nasotracheal Airway
FDA 510(k) K881496 · Polamedco, Inc.
510(k) numberK881496
Submission
- Device name
- Linder Nasotracheal Airway
- Applicant
- Polamedco, Inc.
Santa Monica, CA, US - Received
- April 8, 1988
- Decision date
- May 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal TubeBTR · Traditional | Bryan Medical, Inc. | 09/03/2026SE |
| K253437 | Spiro-VISTABTR · Traditional | Spiro Robotics | 06/12/2026SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | Covidien, LLC | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | Covidien, LLC | 09/25/2025SE |
| K243579 | AeroJet Ventilation CatheterBTR · Traditional | Pipeline Medical Products, LLC | 08/13/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | William Cook Europe Aps | 06/11/2025SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | Flexicare Medical Limited. | 05/20/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | Teleflex Medical | 04/29/2025SE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | Teleflex Incorporated | 02/11/2025SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | Covidien, LLC | 05/20/2024SE |
More from Covidien, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K983000 | Cricothyrotomy TubeBTO · Traditional | 10/27/1999SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | 12/22/1995SE |
| K953793 | IntroscopeBZT · Traditional | 11/29/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | 05/17/1995SE |
| K933596 | Gastric, Catheter, Irrigation & AspirationBSS · Traditional | 02/13/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | 02/10/1995SE |
| K920900 | Polamedco Tracheal and Nasotracheal TubesBTR · Traditional | 03/18/1992SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | 04/19/1990SE |
| K900457 | Cuffed Linder Nasotracheal AirwayBTR · Traditional | 04/16/1990SE |
| K894516 | Visoshield(Tm), Surgical Eye ProtectorFXX · Traditional | 09/12/1989SE |
Questions and answers
When was Linder Nasotracheal Airway cleared by the FDA?
Linder Nasotracheal Airway (K881496) received a 510(k) decision of Substantially Equivalent on May 31, 1988, 53 days after the submission was received.
What is the product code of K881496?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.