510(k) · Cleared
ClearedBayer Diagnostics Clinitest Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Feb 11, 2003 after a 77-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 11, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK023944 Bayer Diagnostics Clinitest Pregnancy TestBayer Corp. · 2003
- Descendant · cites it directly · 7 of its ownK032563 Clinitest HCG Pregnancy TestBayer Healthcare, LLC · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
- Descendant · 4 generations on · 1 of its ownK210069 Minuteful - kidney testHealthy.Io, Ltd. · 2022
- Descendant · 5 generations on · 0 of its ownK222921 Minuteful-kidney testHealthy.Io, Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032563Clinitest HCG Pregnancy TestBayer Healthcare, LLC · 2003 · cites it directly7descendants
- K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · 2 generations on6descendants
- K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · 3 generations on2descendants
- K210069Minuteful - kidney testHealthy.Io, Ltd. · 2022 · 4 generations on1descendant
- K222921Minuteful-kidney testHealthy.Io, Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023944 | Bayer Diagnostics Clinitest Pregnancy Test | Bayer Corp. | 2003 | — |
| +1 | K032563 | Clinitest HCG Pregnancy Test | Bayer Healthcare, LLC | 2003 | 2 |
| +2 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| +3 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
| +4 | K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022 | — |
| +5 | K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 3 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 |
|---|---|---|---|
| * | — | SureStepm hCG/Combo (11) Pregnancy Test Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032563 | Clinitest HCG Pregnancy Test | 2003 | 7 |
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, K032563 (Bayer Healthcare, LLC, 2003) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Bayer Diagnostics ClinitestG9 hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlUlml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023944: Bayer Diagnostics Clinitest 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/K023944
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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