510(k) K253694
K253694 is an FDA 510(k) premarket notification submitted by Natural Cycles Nordic AB for the device "Natural Cycles". The FDA issued a decision of Substantially Equivalent on July 17, 2026. The device falls under product code PYT (Device, Fertility Diagnostic, Contraceptive, Software Application), a Class II device regulated under 21 CFR 884.5370. Natural Cycles Nordic AB has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2026
- Date Received
- November 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fertility Diagnostic, Contraceptive, Software Application
- Device Class
- Class II
- Regulation Number
- 884.5370
- Review Panel
- OB
- Submission Type
Designed to monitor and provide fertility information to prevent pregnancy (contraception).