K250561 is an FDA 510(k) clearance for the Natural Cycles. This device is classified as a Device, Fertility Diagnostic, Contraceptive, Software Application (Class II - Special Controls, product code PYT).
Submitted by Natural Cycles Nordic AB (Stockholm, SE). The FDA issued a Cleared decision on March 21, 2025, 24 days after receiving the submission on February 25, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5370. Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception)..
| 510(k) Number | K250561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2025 |
| Decision Date | March 21, 2025 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PYT - Device, Fertility Diagnostic, Contraceptive, Software Application |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5370 |
| Definition | Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception). |