K162553 is an FDA 510(k) clearance for the AirSpiral Heated Breathing Tube. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Fisher & Paykel Healthcare (Auckland, NZ). The FDA issued a Cleared decision on December 20, 2018, 828 days after receiving the submission on September 13, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K162553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2016 |
| Decision Date | December 20, 2018 |
| Days to Decision | 828 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT - Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |