510(k) · Cleared
ClearedClearplan Easy Ovulation Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unipath, Ltd. · CEP Radioimmunoassay, Luteinizing Hormone
Cleared on Jun 25, 1998 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jun 25, 1998
- Review
- 79 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK981271 Clearplan Easy Ovulation TestUnipath, Ltd. · 1998
- Descendant · cites it directly · 1 of its ownK991386 Early Ovulation Predictor (Stick), One Step Ovulation Predictor…Selfcare, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK013582 Maybe?Mom Mini Ovulation MicroscopeMaybe?Mom · 2003
- Descendant · cites it directly · 0 of its ownK022829 Instant-View LH Ovulation Predicting TestAlfa Scientific Designs, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK994035 Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK991466 Early Ovulation Predictor (Cassette), One Step Ovulation Predictor…Selfcare, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K991386Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…Selfcare, Inc. · 1999 · cites it directly1descendant
- K013582Maybe?Mom Mini Ovulation MicroscopeMaybe?Mom · 2003 · cites it directly0descendants
- K022829Instant-View LH Ovulation Predicting TestAlfa Scientific Designs, Inc. · 2002 · cites it directly0descendants
- K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000 · cites it directly0descendants
- K991466Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…Selfcare, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981271 | Clearplan Easy Ovulation Test | Unipath, Ltd. | 1998 | — |
| +1 | K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick)… | Selfcare, Inc. | 1999 | — |
| +1 | K013582 | Maybe?Mom Mini Ovulation Microscope | Maybe?Mom | 2003 | — |
| +1 | K022829 | Instant-View LH Ovulation Predicting Test | Alfa Scientific Designs, Inc. | 2002 | — |
| +1 | K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | Diagnostic Chemicals, Ltd. | 2000 | — |
| +1 | K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette)… | Selfcare, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation… | 1999 | 1 |
| K013582 | Maybe?Mom Mini Ovulation Microscope | 2003 | 0 |
| K022829 | Instant-View LH Ovulation Predicting Test | 2002 | 0 |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | 2000 | 0 |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation… | 1999 | 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?
- Of its descendants, K991386 (Selfcare, Inc., 1999) has gone furthest, with 1 descendant of its own.
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 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981271: Clearplan Easy Ovulation Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981271
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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