510(k) · Cleared
ClearedEarly Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selfcare, Inc. · CEP Radioimmunoassay, Luteinizing Hormone
Cleared on May 25, 1999 as substantially equivalent to K981271 (Unipath, Ltd., 1998) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- May 25, 1999
- Review
- 34 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894579 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK894579 Clearplan EasyUnipath, Ltd. · 1989
- This deviceK991386 Early Ovulation Predictor (Stick), One Step Ovulation Predictor…Selfcare, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK994035 Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894579 | Clearplan Easy | Unipath, Ltd. | 1989 | — |
| 0 (this device) | K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick)… | Selfcare, Inc. | 1999 | — |
| +1 | K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | Diagnostic Chemicals, Ltd. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981271 | Clearplan Easy Ovulation TestSummary page 1…rially different from the predicate ClearPlan® Easy ovulation tests that are manufactured by Unipath, Ltd., Bedford, UK. and were cleared for use in the United States by K981271 and K894579. Section 6 contains information comparing the new device Ovulation Predictor , to the predicate device, ClearPlan® Ea… | 1998 |
| * | K894579 | Clearplan EasySummary page 1…rent from the predicate ClearPlan® Easy ovulation tests that are manufactured by Unipath, Ltd., Bedford, UK. and were cleared for use in the United States by K981271 and K894579. Section 6 contains information comparing the new device Ovulation Predictor , to the predicate device, ClearPlan® Easy. Descrip… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | 2000 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CEP devicesCEP Radioimmunoassay, Luteinizing Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEP
FDA has decided no CEP device since 2007.
Median 510(k) review, days · CEP
Too few CEP 510(k)s in any year since 2007 to give a median.
Recalls per year · CEP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEP
1in 2023
MAUDE reports naming product code CEP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991386: Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991386
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026