# K193330: Clue Birth Control

- Pathway: 510(k) (Abbreviated)
- Applicant: Biowink GmbH
- Decided: Feb 18, 2021 after 444 days
- Product code: PYT (Device, Fertility Diagnostic, Contraceptive, Software Application)
- Device class: 2
- Regulation: 21 CFR 884.5370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170052 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170052: Natural Cycles, Natural Cycles Nordic AB (2018) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K193330
Methodology: https://510kreport.com/methodology