510(k) · Cleared
Recalled · 2011Clinitest HCG Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Dec 23, 2003 as substantially equivalent to K023944 (Bayer Corp., 2003) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 23, 2003
- Review
- 125 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K020801 (2002). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020801 Quickvue One-Step HCG-ComboQuidel Corp. · 2002
- This deviceK032563 Clinitest HCG Pregnancy TestBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
- Descendant · 3 generations on · 1 of its ownK210069 Minuteful - kidney testHealthy.Io, Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK222921 Minuteful-kidney testHealthy.Io, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK171521 DUS R-50S (Urine Chemistry system)DFI Co., Ltd. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · cites it directly6descendants
- K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · 2 generations on2descendants
- K210069Minuteful - kidney testHealthy.Io, Ltd. · 2022 · 3 generations on1descendant
- K222921Minuteful-kidney testHealthy.Io, Ltd. · 2023 · 4 generations on0descendants
- K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020801 | Quickvue One-Step HCG-Combo | Quidel Corp. | 2002 | — |
| 0 (this device) | K032563 | Clinitest HCG Pregnancy Test | Bayer Healthcare, LLC | 2003 | — |
| +1 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| +2 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
| +3 | K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022 | — |
| +4 | K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023 | — |
| +2 | K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K023944 | Bayer Diagnostics Clinitest Pregnancy TestSummary page 1…Test hCG Combo Manufacturer: Bayer Healthcare, LLC Quidel Corporation 510(k) #K023944 #K020801 Number: Bayer Healthcare, LLC… | 2003 |
| * | K020801 | Quickvue One-Step HCG-ComboSummary page 1…hCG Combo Manufacturer: Bayer Healthcare, LLC Quidel Corporation 510(k) #K023944 #K020801 Number: Bayer Healthcare, LLC 14 Clinitest hCG Pregna… | 2002 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | 2009 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2011 | Not classified | Z-0972-2012 | Process control | A potential for false positive or increase in borderline results with patients and commercially available negative control material. |
| Apr 4, 2008 | Not classified | Z-1715-2008 | Component design/selection | False negative hCG results due to decreased sensitivity |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K091216 (Siemens Healthcare Diagnostics, 2009) has gone furthest, with 6 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 Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. This test is used to obtain a Clinitek Status analyzer result of positive, borderline or negative and is intended for near patient (point-of-care) and centralized laboratory locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032563: Clinitest HCG 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/K032563
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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