# K122337: Ovusense

- Pathway: 510(k) (Traditional)
- Applicant: Fertility Focus, Ltd.
- Decided: Aug 6, 2013 after 369 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: 4 generations back to K914085 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102499: Duofertility, Cambridge Temperature Concepts, Ltd. (2011) Summary page 1.
- K904211: Bioself 2000 Fertility Indicator, Bioself, Inc. (1992) Summary page 1.

## Indications for use
The Fertility Focus OvuSense Fertility Monitor (Fertility Focus OvuSense Fertility Monitor Starter Kit M009-US, which includes Reader M010-US and Personal Sensor M011) is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).

Source page: https://510kreport.com/device/K122337
Methodology: https://510kreport.com/methodology