510(k) · Cleared
ClearedUnimark Home Pregnancy Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotech Atlantic, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Nov 21, 2003 as substantially equivalent to K941090 (Biotech Atlantic, Inc., 1994) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1994. 15 later devices descend from it.
- Decided
- Nov 21, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941090 (1994). 15 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- 1 generation backK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- This deviceK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK173229 Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK222305 MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK192123 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test…Qingdao Hightop Biotech Co., Ltd. · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K043443One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005 · cites it directly14descendants
- K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018 · 2 generations on2descendants
- K222305MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022 · 3 generations on1descendant
- K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd. · 2020 · 2 generations on1descendant
- K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP…Qingdao Hightop Biotech Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| −1 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| 0 (this device) | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| +1 | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| +2 | K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | — |
| +3 | K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022 | — |
| +2 | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech (Hangzhou) Co., Ltd. | 2020 | — |
| +2 | K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip… | Qingdao Hightop Biotech Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K941090 | Unistep HCG Pregnancy Test StripSummary page 1…Classification: Human Chorionic Gonadotropin (hCG) Test System C. Legally Marketed Devices UniMark@hCG Pregnancy Test (device and strip), K941090 UniMark@Mdstreatn Pregnancy Test Stick, K960 174 D. Device description The UniMark@Home Pregnancy Test… | 1994 |
| * | K960174 | Unimark Midstream Pregnancy Test StickSummary page 1…n (hCG) Test System C. Legally Marketed Devices UniMark@hCG Pregnancy Test (device and strip), K941090 UniMark@Mdstreatn Pregnancy Test Stick, K960 174 D. Device description The UniMark@Home Pregnancy Test Device is a colored solid-phase Chromatographic I… | 1996 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043443 | One Step HCG Urine Pregnancy Test | 2005 | 14 |
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?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K043443 (Guangzhou Wondfo Biotech Co., Ltd., 2005) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K941090.
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?
UniMark@Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin OCG) in urine. It is intended for consumer use at home.
It is indicated for use in the early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032992: Unimark Home Pregnancy Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032992
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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