# K973860: Ovulon Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Conception Technology, Inc.
- Decided: Jan 7, 1998 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that yields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina. The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques. The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception. After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.

Source page: https://510kreport.com/device/K973860
Methodology: https://510kreport.com/methodology