# K050094: Lady Comp Usa

- Pathway: 510(k) (Traditional)
- Applicant: Lady Comp USA
- Decided: Apr 20, 2006 after 461 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Petit Sophia, Computerized Basal Body Thermometer, Model No. BT-1I4E: named in the summary without a submission number

## Most influential descendants
- K102499: Duofertility (2011), 1 descendant of its own
- K200163: Ava Fertility Tracker (2021), 0 descendants of its own
- K122337: Ovusense (2013), 0 descendants of its own

## Indications for use
Lady-Comp® USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).

Source page: https://510kreport.com/device/K050094
Methodology: https://510kreport.com/methodology