Cleared Abbreviated

K193330 - Clue Birth Control (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway.

K193330 · Biowink GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
444d
Days
Class 2
Risk

K193330 is an FDA 510(k) clearance for the Clue Birth Control. Classified as Device, Fertility Diagnostic, Contraceptive, Software Application (product code PYT), Class II - Special Controls.

Submitted by Biowink GmbH (Berlin, DE). The FDA issued a Cleared decision on February 18, 2021 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5370 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Biowink GmbH devices

Submission Details

510(k) Number K193330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date February 18, 2021
Days to Decision 444 days
Submission Type Abbreviated
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
284d slower than avg
Panel avg: 160d · This submission: 444d
Pathway characteristics
Standards-based clearance path.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02833922 Completed Observational

Effectiveness and Efficacy of Dynamic Optimal Timing, a Smart Phone App for Avoiding Pregnancy: an Observational Study

Perfect- and Typical-use Effectiveness of the Dot Fertility App Over 13 Cycles: Results From a Prospective Contraceptive Effectiveness Trial

718
Patients (actual)
Condition studied Desire to Avoid Pregnancy
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Victoria Jennings, PhD
Sponsor Georgetown University
Started 2016-09-01 → Primary completion 2019-09-30
Primary outcome
Pregnancy Rates
Secondary outcome
Intent to Continue Using the Method at Study Completion
View full study on ClinicalTrials.gov