K251674 is an FDA 510(k) clearance for the Fenom Flo™ FeNO Monitoring System. This device is classified as a System, Test, Breath Nitric Oxide (Class II - Special Controls, product code MXA).
Submitted by Mgc Diagnostics Corporation (St. Paul, US). The FDA issued a Cleared decision on November 26, 2025, 180 days after receiving the submission on May 30, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3080.
| 510(k) Number | K251674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | November 26, 2025 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MXA - System, Test, Breath Nitric Oxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3080 |