510(k) · Cleared
ClearedDavid Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Runbio Biotech Co.,Ltd · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Mar 28, 2018 as substantially equivalent to K043443 (Guangzhou Wondfo Biotech Co., Ltd., 2005) after a 208-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 28, 2018
- Review
- 208 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941090 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- 3 generations backK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- 2 generations backK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- 1 generation backK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- This deviceK172627 David Home Pregnancy Test Cassette, David Professional Pregnancy…Runbio Biotech Co.,Ltd · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| −3 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| −2 | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| −1 | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| 0 (this device) | K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | Runbio Biotech Co.,Ltd | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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? (1)
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 |
|---|---|---|---|
| * | K043443 | One Step HCG Urine Pregnancy TestSummary page 7…antibody. F. Substantial Equivalence Information 1.Predicate Device Name(s)： Wondfo One Step HCG Urine Pregnancy Test 2.Predicate 510（K）Number(s): k043443 3.Comparison with predicate Similarities and Differences Item… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 8 ancestors has a recall.
- 8 other devices also cite its predicate K043443.
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. 2018, this device’s year, is highlighted.
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?
David Home Pregnancy Test Cassette is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy, based on lateral flow immunoassay. It is intended for the Over-the-Counter Use only.
David Professional Pregnancy Test Cassette is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy, based on lateral flow immunoassay. It is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172627: David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172627
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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