Cleared Special

K250561 - Natural Cycles (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250561 · Natural Cycles Nordic AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
24d
Days
Class 2
Risk

K250561 is an FDA 510(k) clearance for the Natural Cycles. Classified as Device, Fertility Diagnostic, Contraceptive, Software Application (product code PYT), Class II - Special Controls.

Submitted by Natural Cycles Nordic AB (Stockholm, SE). The FDA issued a Cleared decision on March 21, 2025 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5370 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natural Cycles Nordic AB devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 160d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PYT Device, Fertility Diagnostic, Contraceptive, Software Application
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5370
Definition Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.