Inspiron Double Swivel Trach Adapter
FDA 510(k) K860838 · Inspiron Corp.
510(k) numberK860838
Submission
- Device name
- Inspiron Double Swivel Trach Adapter
- Applicant
- Inspiron Corp.
Rancho Cucamonga, CA, US - Received
- March 5, 1986
- Decision date
- April 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K942392 | Airway Connector with Flex TubeBZA · Traditional | Mallinckrodt Medical | 08/22/1994SE |
More from Mallinckrodt Medical
| 510(k) | Device | Decision |
|---|---|---|
| K850346 | Oxygen ConcentratorCAW · Traditional | 02/04/1985SE |
| K843932 | Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional | 10/18/1984SE |
| K840935 | Manual Resuscitation SystemBTM · Traditional | 04/05/1984SE |
| K841158 | Nebulo 28 Nebulizer KitBTT · Traditional | 03/30/1984SE |
| K840418 | Inspiratory/Expiratory Muscle ExercisBWF · Traditional | 02/17/1984SE |
| K834290 | Inspiron Liquid Oxygen SystemBYJ · Traditional | 02/04/1984SE |
| K772072 | Manifold & Nebu. for Doub. Line Mach.CAF · Traditional | 11/15/1977SE |
| K772071 | Manifold & Nebu. for Single Line Mach.CAF · Traditional | 11/15/1977SE |
| K772070 | Ventilator Setup, VolumeCAF · Traditional | 11/15/1977SE |
| K772069 | Vol. Ventilator Setup W/Out NebulizerBZO · Traditional | 11/15/1977SE |
Questions and answers
When was Inspiron Double Swivel Trach Adapter cleared by the FDA?
Inspiron Double Swivel Trach Adapter (K860838) received a 510(k) decision of Substantially Equivalent on April 9, 1986, 35 days after the submission was received.
What is the product code of K860838?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.