510(k) · Cleared
Recalled · Class II · 2014Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Oct 9, 2009 as substantially equivalent to K031947 (Bayer Healthcare, LLC, 2003) and 1 other predicate after a 165-day review. Its family tree reaches back 2 generations to 1991. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 9, 2009
- Review
- 165 days
- Class
- Class II
- Product code
- JIL
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905396 (1991). 8 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 1 generation backK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- This deviceK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
- Descendant · 2 generations on · 1 of its ownK210069 Minuteful - kidney testHealthy.Io, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK222921 Minuteful-kidney testHealthy.Io, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK171521 DUS R-50S (Urine Chemistry system)DFI Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK160372 Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · cites it directly2descendants
- K210069Minuteful - kidney testHealthy.Io, Ltd. · 2022 · 2 generations on1descendant
- K222921Minuteful-kidney testHealthy.Io, Ltd. · 2023 · 3 generations on0descendants
- K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd. · 2018 · cites it directly0descendants
- K160372Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −1 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| 0 (this device) | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
| +2 | K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022 | — |
| +3 | K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023 | — |
| +1 | K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018 | — |
| +1 | K160372 | Uritek TC-201 Urine Chemistry Test System | Teco Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JIL? 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 JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K031947 | Bayer Clinitek Status AnalyzerSummary page 1…Predicate Device Device Name Clinitek Status Common name Urine Chemistry Analyzer 510(k) Number K031947 and K032563 Manufacturer Siemens Healthcare Diagnostics Limited Device Description The Clinitek Status®+ Analy… | 2003 |
| * | K032563 | Clinitest HCG Pregnancy TestSummary page 1…Predicate Device Device Name Clinitek Status Common name Urine Chemistry Analyzer 510(k) Number K031947 and K032563 Manufacturer Siemens Healthcare Diagnostics Limited Device Description The Clinitek Status®+ Analyzer, a devic… | 2003 |
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2014 | Class II | Z-0083-2015 | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
| Sep 19, 2014 | Class II | Z-0082-2015 | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
| Sep 19, 2014 | Class II | Z-0081-2015 | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. |
| Feb 26, 2013 | Class III | Z-1545-2014 | Reprocessing Controls | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K141874 (Yd Diagnostics Corp., 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K031947.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, 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 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Clinitek Status®+ Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic…
Read the full statement (117 words)
The Clinitek Status®+ Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.
This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
These measurements are used to assist diagnosis in the following areas:
Kidney Function
Urinary tract infections
Metabolic disorders (e.g. diabetes mellitus)
Liver Function
Pregnancy
Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only.
The Clinitek Status®+ Analyzer is intended for near patient (point-of-care). facilities and centralized laboratory locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091216
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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