# K981207: Clearplan Easy Fertility Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Oct 28, 1998 after 209 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K020808: Fertilite OV (2002), 0 descendants of its own
- K012252: Quik-Check Ovulation Predictor (2001), 0 descendants of its own

## Indications for use
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman’s cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy. The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists. The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility. CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual. CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.

Source page: https://510kreport.com/device/K981207
Methodology: https://510kreport.com/methodology