Ohio Non-Reusable Tracheal Tube Majill
FDA 510(k) K812880 · Airco/Ohio Medical Products
510(k) numberK812880
Submission
- Device name
- Ohio Non-Reusable Tracheal Tube Majill
- Applicant
- Airco/Ohio Medical Products
Mchenry, IL, US - Received
- October 14, 1981
- Decision date
- November 24, 1981
- 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 |
|---|---|---|
| K833459 | Coaxial Vol. Ventilator CircuitBZO · Traditional | 01/10/1984SE |
| K833452 | Ohio GMS AbsorberBSF · Traditional | 11/29/1983SE |
| K832418 | Ohio Temperature SimulatorFMZ · Traditional | 09/12/1983SE |
| K832565 | Ohio 5400 Volume MonitorBZK · Traditional | 09/01/1983SE |
| K832185 | Ohio Model 922 SpirometerBZG · Traditional | 08/12/1983SE |
| K830446 | Oxygen Monitor Ohio 5100CCL · Traditional | 03/24/1983SE |
| K822456 | Ohio V5A Anesthesia VentilatorCBK · Traditional | 09/21/1982SE |
| K813476 | Ohio Volume Incentive SpirometerBWF · Traditional | 12/31/1981SE |
| K812879 | Ohio Non-Reusable Tracheal Tube MurphyBTR · Traditional | 11/24/1981SE |
| K811413 | Dabc Nonconductive Pediat. Anesth. CirCAI · Traditional | 06/02/1981SE |
Questions and answers
When was Ohio Non-Reusable Tracheal Tube Majill cleared by the FDA?
Ohio Non-Reusable Tracheal Tube Majill (K812880) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 41 days after the submission was received.
What is the product code of K812880?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.