Is Clue Birth Control FDA cleared?

FDA's records list K193330 for Clue Birth Control from Biowink GmbH: 510(k), decision date Feb 18, 2021, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K193330?

PYT: Device, Fertility Diagnostic, Contraceptive, Software Application, regulated under 21 CFR 884.5370, class 2.

FDA 510(k) · Biowink

K193330: Clue Birth Control (Biowink GmbH)

Biowink GmbH received FDA 510(k) K193330 for Clue Birth Control, with a decision date of Feb 18, 2021 (substantially equivalent).

Prescription or OTC: Unknown (no FDA document we parsed states it).

FDA record for K193330 FDA summary or statement (PDF)

FDA facts

Official fields for K193330
FDA number	K193330
Pathway	510(k)
Applicant	Biowink GmbH
Device name	Clue Birth Control
Product code	PYT: Device, Fertility Diagnostic, Contraceptive, Software Application
Regulation (21 CFR)	884.5370
Device class	Class 2
Date received	Dec 2, 2019
Decision date	Feb 18, 2021
Decision	Substantially Equivalent (SESE)
510(k) type	Abbreviated

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

Clue Birth Control is a software application for contraception for women ages 18 - 45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable 20 - 40 day cycles, who have not recently used hormonal birth control.

Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.

Predicates parsed from FDA documents

FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.

DEN170052 Natural Cycles (Natural Cycles)

ChatPPG interpretation

A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.

Product code PYT is "Device, Fertility Diagnostic, Contraceptive, Software Application", class 2, 21 CFR 884.5370. FDA's definition: "Designed to monitor and provide fertility information to prevent pregnancy (contraception)."

Our labels for filtering: claim Fertility / cycle, sensor Other. These are heuristics, not FDA fields.