# K200163: Ava Fertility Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Ava AG
- Decided: Jan 19, 2021 after 363 days
- Product code: LHD (Device, Fertility Diagnostic, Proceptive)
- Device class: U
- 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 K050094 (2006). 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)
- K050094: Lady Comp Usa, Lady Comp USA (2006) Summary page 4.

## Indications for use
The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).

Source page: https://510kreport.com/device/K200163
Methodology: https://510kreport.com/methodology