# K102499: Duofertility

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Temperature Concepts, Ltd.
- Decided: Dec 20, 2011 after 476 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: 3 generations back to K914085 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021978: Petit Sophia, Nishitomo Co., Inc. (2003) Summary page 2.
- K050094: Lady Comp Usa, Lady Comp USA (2006) Summary page 2.
- K033534: Vitalsense, Mini-Mitter Co., Inc. (2004) Summary page 2.

## Most influential descendants
- K122337: Ovusense (2013), 0 descendants of its own

## Indications for use
The DuoFertility Monitor 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/K102499
Methodology: https://510kreport.com/methodology