Cleared Traditional

K241006 - Natural Cycles (FDA 510(k) Clearance)

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

K241006 · Natural Cycles Nordic AB · Obstetrics & Gynecology device
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Jul 2024
Decision
90d
Days
Class 2
Risk

K241006 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 July 11, 2024 after a review of 90 days - within the typical 510(k) review window.

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 K241006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2024
Decision Date July 11, 2024
Days to Decision 90 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 Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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.