# K981271: Clearplan Easy Ovulation Test

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: Jun 25, 1998 after 79 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- 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.
5 later devices descend from it; 5 cite it directly.
0 of 6 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
- K991386: Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick) (1999), 1 descendant of its own
- K013582: Maybe?Mom Mini Ovulation Microscope (2003), 0 descendants of its own
- K022829: Instant-View LH Ovulation Predicting Test (2002), 0 descendants of its own
- K994035: Immunodip Urinary Albumin Screen, Model 790-01, 790-15 (2000), 0 descendants of its own
- K991466: Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation Predictor (Cassette) (1999), 0 descendants of its own

## Indications for use
The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation via a urine test. The CLEARPLAN EASY Ovulation Test detects the LH surge in a woman’s urine. The product will be made available over-the-counter through pharmacies and drug stores.

Source page: https://510kreport.com/device/K981271
Methodology: https://510kreport.com/methodology