510(k) · Cleared
ClearedUnistep HCG Pregnancy Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotech Atlantic, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Jun 2, 1994 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jun 2, 1994
- Review
- 86 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- Descendant · cites it directly · 16 of its ownK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- Descendant · cites it directly · 15 of its ownK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- Descendant · 2 generations on · 14 of its ownK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- Descendant · 3 generations on · 2 of its ownK173229 Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK222305 MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K960174Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996 · cites it directly16descendants
- K032992Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003 · cites it directly15descendants
- K043443One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005 · 2 generations on14descendants
- K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018 · 3 generations on2descendants
- K222305MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| +1 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| +1 | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| +2 | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| +3 | K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | — |
| +4 | K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 183 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, K960174 (Biotech Atlantic, Inc., 1996) has gone furthest, with 16 descendants of its own.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K941090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941090: Unistep HCG Pregnancy Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941090
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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