510(k) · Cleared
ClearedClearplan Easy
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 Oct 12, 1989 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 12, 1989
- Review
- 80 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK894579 Clearplan EasyUnipath, Ltd. · 1989
- Descendant · cites it directly · 1 of its ownK991386 Early Ovulation Predictor (Stick), One Step Ovulation Predictor…Selfcare, Inc. · 1999
- Descendant · 2 generations on · 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 3 of 3 · See all- K991386Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…Selfcare, Inc. · 1999 · cites it directly1descendant
- K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000 · 2 generations on0descendants
- 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) | K894579 | Clearplan Easy | Unipath, Ltd. | 1989 | — |
| +1 | K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick)… | Selfcare, Inc. | 1999 | — |
| +2 | 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 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 | — |
https://510kreport.com/device/K894579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894579: Clearplan Easy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894579
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026