Airway Connector with Flex Tube
FDA 510(k) K942392 · Mallinckrodt Medical
510(k) numberK942392
Submission
- Device name
- Airway Connector with Flex Tube
- Applicant
- Mallinckrodt Medical
Argyle, NY, US - Received
- May 19, 1994
- Decision date
- August 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZA – Connector, Airway (Extension)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5810
- Specialty
- Anesthesiology
Other 510(k)s with product code BZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083702 | Trach-AssistBZA · Traditional | Mergenet Medical | 03/05/2009SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | Polamedco, Inc. | 12/22/1995SE |
| K954197 | Disposable Flex TubeBZA · Traditional | Engstrom Medical | 10/26/1995SE |
| K953786 | Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952824 | Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional | Intertex Medical, Inc. | 07/20/1995SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | Catheter Research, Inc. | 04/14/1995SE |
| K944532 | Prima, Inc. Ventilator HosesBZA · Traditional | Prima, Inc. | 12/02/1994SE |
| K944535 | Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K944534 | Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K941026 | Thayer Mask to Mouthpiece Adapter/ConnectorBZA · Traditional | Thayer Medical Corp. | 08/18/1994SE |
More from Thayer Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K082520 | Sealguard Evac Endotracheal and Endotracheal TubesBTR · Special | 10/02/2008SE |
| K051416 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner CannulaJOH · Special | 06/16/2005SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | 12/29/1997SE |
| K971267 | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…JOH · Traditional | 09/25/1997SE |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…JOH · Traditional | 06/26/1997SE |
| K955721 | Cuffed Oropharyngeal Airway (Copa)CAE · Traditional | 03/28/1997SE |
| K965132 | Hi-Lo Evac and Evac II Endotracheal TubesBTR · Traditional | 03/20/1997SE |
| K962045 | Anesthesia Breathing Circuit/Anesthesia Breathing KitCAH · Traditional | 11/26/1996SE |
| K962173 | Shikey Tracheostomy Tubes and AccessoriesJOH · Traditional | 10/04/1996SE |
| K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedJOH · Traditional | 03/13/1996SE |
Questions and answers
When was Airway Connector with Flex Tube cleared by the FDA?
Airway Connector with Flex Tube (K942392) received a 510(k) decision of Substantially Equivalent on August 22, 1994, 95 days after the submission was received.
What is the product code of K942392?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.