# K021978: Petit Sophia

- Pathway: 510(k) (Traditional)
- Applicant: Nishitomo Co., Inc.
- Decided: Apr 8, 2003 after 295 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 K901512 (1990). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K901512: L Sophia, Nishitomo Co., Inc. (1990) Summary page 1.

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

## Indications for use
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/K021978
Methodology: https://510kreport.com/methodology