K160109 is an FDA 510(k) clearance for the Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber. This device is classified as a Holding Chambers, Direct Patient Interface (Class II - Special Controls, product code NVP).
Submitted by Thayer Medical Corporation (Tucson, US). The FDA issued a Cleared decision on May 19, 2017, 486 days after receiving the submission on January 19, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630. Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles.
| 510(k) Number | K160109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2016 |
| Decision Date | May 19, 2017 |
| Days to Decision | 486 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NVP - Holding Chambers, Direct Patient Interface |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |
| Definition | Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles |