510(k) · Cleared
ClearedMinistick Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanguard Biomedical Corp. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on May 1, 1996 as substantially equivalent to K914253 (Vanguard Biomedical Corp., 1991) after a 69-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- May 1, 1996
- Review
- 69 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914253 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914253 Proclinic One Step Pregnancy TestVanguard Biomedical Corp. · 1991
- This deviceK960733 Ministick Pregnancy TestVanguard Biomedical Corp. · 1996
- Descendant · cites it directly · 1 of its ownK172512 ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK180771 Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914253 | Proclinic One Step Pregnancy Test | Vanguard Biomedical Corp. | 1991 | — |
| 0 (this device) | K960733 | Ministick Pregnancy Test | Vanguard Biomedical Corp. | 1996 | — |
| +1 | K172512 | ACRO HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018 | — |
| +2 | K180771 | Acro HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K914253 | Proclinic One Step Pregnancy TestSummary page 4…6 clinical urine specimens ( 55 positive and 151 negative) were assayed with the MiniStick Pregnancy Test and with the HOMECLINIC One-Step Pregnancy Test {510 (k) Number K914253) following package directions. The MiniStick Pregnancy Testis chemically and structurally identical to the HOMECLINIC One-Step Pr… | 1991 |
| * | — | ANSWER 1-Step Pregnancy Test Named without a submission number | |
| * | — | 1 Step ADVANCE Pregnancy Test Named without a submission number | |
| * | — | Conceive Pregnancy Test Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172512 | ACRO HCG Pregnancy Rapid Test | 2018 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K172512 (Acro Biotech, Inc., 2018) has gone furthest, with 1 descendant 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?
The MiniStick Pregnancy Test is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960733 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960733: Ministick Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960733
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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