# DEN170052: Natural Cycles

- Pathway: De Novo (Post-NSE)
- Applicant: Natural Cycles Nordic AB
- Decided: Aug 10, 2018 after 324 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K202897: Natural Cycles (2021), 4 descendants of its own
- K231274: Natural Cycles (2023), 3 descendants of its own
- K253694: Natural Cycles (2026), 0 descendants of its own
- K250561: Natural Cycles (2025), 0 descendants of its own
- K241006: Natural Cycles (2024), 0 descendants of its own

## 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/DEN170052
Methodology: https://510kreport.com/methodology