K250445 is an FDA 510(k) clearance for the Fast Warm - NX. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Fujifilm Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on September 12, 2025, 210 days after receiving the submission on February 14, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K250445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2025 |
| Decision Date | September 12, 2025 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL - Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |