Cleared Traditional

K202897 - Natural Cycles (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202897 · Natural Cycles Nordic AB · Obstetrics & Gynecology device
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Jun 2021
Decision
268d
Days
Class 2
Risk

K202897 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 June 24, 2021 after a review of 268 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5370 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Natural Cycles Nordic AB devices

Submission Details

510(k) Number K202897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2020
Decision Date June 24, 2021
Days to Decision 268 days
Submission Type Traditional
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
108d slower than avg
Panel avg: 160d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.