Natural Cycles— 510(k) K253694
Substantially EquivalentNatural Cycles Nordic AB
FDA 510(k) clearance K253694 for Natural Cycles, Substantially Equivalent on 2026-07-17. Applicant: Natural Cycles Nordic AB. Device class: 2.
Summary
Natural Cycles from Natural Cycles Nordic is filed under PYT, software application fertility diagnostic contraceptive devices. The record doesn't describe the app's inputs or outputs.
Class II, 21 CFR 884.5370. Obstetrics and Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Natural Cycles filed from Stockholm, Sweden. Review took 238 calendar days (November 21, 2025 to July 17, 2026).
Clearance details
- Applicant
- Natural Cycles Nordic AB
- Product code
- Product code PYT
- Device class
- Class 2
- Regulation
- 21 CFR 884.5370
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code PYT
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