Clue Birth Control

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K193330Ref Clue (iOS)

by BioWink GmbH

Identity

Trade Name: Clue App FDA UDI
Generic Name: Self-care monitoring/reporting software FDA UDI
Device Name: Clue EUDAMED
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. FDA UDI
Model / Reference: Clue (iOS) EUDAMED
iOS FDA UDI
Description: Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260749840039 EUDAMEDFDA UDI
Basic UDI-DI: 426074984ClueND EUDAMED
510(k) Number: K193330 FDA 510(k)
FDA Product Code: PYT FDA 510(k)
LHD FDA UDI
EMDN Code: V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term: Self-care monitoring/reporting software FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA 510(k)
U FDA UDI
Legislation / Framework: 21 CFR Part 884.5370 FDA 510(k)
Regulation Number: 884.5370 FDA 510(k)
Special Device Type: Software EUDAMED
Market of Registration: Germany EUDAMED
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Clue Birth Control is a Fertility Diagnostic, Contraceptive Software Application, designed to assist users in tracking menstrual cycles and predicting ovulation to aid in contraceptive planning. As a digital health tool, it provides insights into fertility windows based on user-input data such as cycle length, symptoms, and basal body temperature.

The device is supplied as a mobile application for Android and iOS platforms, requiring no physical hardware. It operates as a single-use per user account with no sterility requirements, as it is not a medical device in the traditional sense but rather a regulated software application under FDA 510(k) clearance and MDR compliance. No MRI safety considerations apply, and its use is limited to personal fertility tracking and contraceptive planning within the scope of its authorized indications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K193330	Class II	Active

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Manufacturer

Manufacturer: BioWink GmbH

Sources (3)

FDA 510(k) K193330 24 fields · synced Oct 6, 2026
FDA UDI 0ee4863d-5a5e-4db1-baf5-3ac452232096 33 fields · synced May 30, 2026
EUDAMED 4c9bdf51-3c46-4ab4-8e3d-8fd4e70caa63 61 fields · synced Jul 26, 2026