# K241006: Natural Cycles

- Pathway: 510(k) (Traditional)
- Applicant: Natural Cycles Nordic AB
- Decided: Jul 11, 2024 after 90 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: 3 generations back to DEN170052 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231274: Natural Cycles, Natural Cycles Nordic AB (2023) Summary page 5.

## Indications for use
Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).

Source page: https://510kreport.com/device/K241006
Methodology: https://510kreport.com/methodology