# K020808: Fertilite OV

- Pathway: 510(k) (Traditional)
- Applicant: Pheromone Sciences Corp.
- Decided: Sep 23, 2002 after 195 days
- Product code: NGE (Test, Luteinizing Hormone (Lh), Over The Counter)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 K850579 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981207: Clearplan Easy Fertility Monitor, Unipath, Ltd. (1998) Summary page 1.
- K850579: Cue Fertility Monitor, Zetek, Inc. (1985) Summary page 1.
- K002726: Tcoyf Fertility Software Version 1.0, Ovusoft, LLC (2001)

## Indications for use
Fertilitt OVT” (PSC Fertility Monitor) is an over-the-counter (“OTC”) in vitro diagnostic (“IVD”) device intended for use by women as an aid in conception by measuring hormone-induced changes in the composition of the perspiration on the skin during the menstrual cycle. Properly used, it gives more notice for conceiving and is not invasive. It is NOT to be used for contraception.

Source page: https://510kreport.com/device/K020808
Methodology: https://510kreport.com/methodology