K250322 is an FDA 510(k) clearance for the Respond OC Conserving Regulator (130-0800). This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).
Submitted by Responsive Respiratory (St. Louis, US). The FDA issued a Cleared decision on July 24, 2025, 170 days after receiving the submission on February 4, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K250322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2025 |
| Decision Date | July 24, 2025 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NFB - Conserver, Oxygen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |