# K990223: Modification of Clearplan Easy Fertility Monitor

- Pathway: 510(k) (Special)
- Applicant: Unipath, Ltd.
- Decided: Feb 24, 1999 after 30 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 CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid to conception by identifying those days in a woman’s cydle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and packs of test sticks. The product will be made available to the consumer through pharmacies and drug stores. The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of acts of intercourse to be recorded electronically and the data to be collated on the computer with the information collected by the CLEARPLAN EASY FERTILITY MONITOR. The CLEARPLAN DATA TRANSFER SYSTEM consists of a software controlled electronic card reader, a personal computer software package, electronic memory cards and user instructions. The target market for the CLEARPLAN DATA TRANSFER SYSTEM is women who have purchased the CLEARPLAN EASY FERTILITY MONITOR. In addition the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists. The CLEARPLAN DATA TRANSFER SYSTEM is intended to be used to transfer data which have already been collected by the the CLEARPLAN EASY FERTILITY MONITOR to a computer. The information which is presented to the user of the device is limited to that which the they could have recorded on paper on a daily basis by noting the indications given by the CLEARPLAN EASY FERTILITY MONITOR and the user’s own activities. Therefore the CLEARPLAN DATA TRANSFER SYSTEM does not affect the intended use of the CLEARPLAN EASY FERTILITY MONITOR or the fundamental scientific technology of the CLEARPLAN EASY FERTILITY MONITOR.

Source page: https://510kreport.com/device/K990223
Methodology: https://510kreport.com/methodology