510(k) · Cleared
ClearedClearblue Easy Early Result Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unipath, Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Nov 9, 2001 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it.
- Decided
- Nov 9, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK013372 Clearblue Easy Early Result Pregnancy TestUnipath, Ltd. · 2001
- Descendant · cites it directly · 19 of its ownK030258 First Response Pregnancy TestArmkel, LLC · 2003
- Descendant · 2 generations on · 17 of its ownK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
- Descendant · 3 generations on · 13 of its ownK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · Recalled
- Descendant · 4 generations on · 6 of its ownK150022 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG…Guangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK123567 First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K030258First Response Pregnancy TestArmkel, LLC · 2003 · cites it directly19descendants
- K083716First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · 2 generations on17descendants
- K123436First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · 3 generations on13descendants
- K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test…Guangzhou Wondfo Biotech Co., Ltd. · 2015 · 4 generations on6descendants
- K123567First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013372 | Clearblue Easy Early Result Pregnancy Test | Unipath, Ltd. | 2001 | — |
| +1 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| +2 | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | 1 |
| +3 | K123436 | First Response Early Result Pregnancy Test | Church & Dwight Co., Inc. | 2013 | 2 |
| +4 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +3 | K123567 | First Response Gold Digital Pregnancy Test | Church & Dwight Co., Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 LCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCX device
- #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030258 | First Response Pregnancy Test | 2003 | 19 |
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, K030258 (Armkel, LLC, 2003) has gone furthest, with 19 descendants of its own.
How does its category compare?
All LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, 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 | 4 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the
detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine,
and is indicated for use from four days before the expected missed -period.
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/K013372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013372: Clearblue Easy Early Result Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013372
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026