510(k) Report

510(k) · Cleared

Cleared

Bayer Clinitek Status Analyzer

K031947510(k) TraditionalCleared Dec 19, 2003178-day reviewClass I21 CFR 862.2900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bayer Healthcare, LLC · KQO Automated Urinalysis System

Cleared on Dec 19, 2003 as substantially equivalent to K960546 (Bayer Corp., 1996) and 3 other predicates after a 178-day review. Its family tree reaches back 1 generation to 1991. 16 later devices descend from it.

Decided
Dec 19, 2003
Review
178 days
Class
Class I
Product code
KQO
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K905396 (1991). 4 ancestors in all. 16 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor2009: 1 descendant cleared2007: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2015: 2 descendants cleared2012: 1 descendant cleared2018: 2 descendants cleared2016: 2 descendants cleared2024: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK905396 · Hemastix Reagent Strips · Heraeus Kulzer, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K905396 · Hemastix Reagent Strips · Heraeus Kulzer, Inc. · 19910
  1. Root · 1 generation backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
  2. This deviceK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
  3. Descendant · cites it directly · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
  4. Descendant · cites it directly · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
  5. Descendant · cites it directly · 3 of its ownK070929 Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007
  6. Descendant · 2 generations on · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
  7. Descendant · 3 generations on · 1 of its ownK210069 Minuteful - kidney testHealthy.Io, Ltd. · 2022

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12011: 12012: 12014: 12015: 22016: 22018: 22019: 12022: 12023: 12024: 12026: 1
2007high 2 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 16 · See all
  • K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · cites it directly6descendants
  • K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · cites it directly3descendants
  • K070929Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007 · cites it directly3descendants
  • K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · 2 generations on2descendants
  • K210069Minuteful - kidney testHealthy.Io, Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905396Hemastix Reagent StripsHeraeus Kulzer, Inc.1991—
0 (this device)K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC2003—
+1K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics20094
+1K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc.2014—
+1K070929Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc.2007—
+2K141874Uriscan OptimaYd Diagnostics Corp.2015—
+3K210069Minuteful - kidney testHealthy.Io, Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201110
201210
201410
201520
201620
201820
201910
202210
202310
202410
202610
FIG. 1 — Lineage of K031947, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K960546Clinitek 50 Urine Chemistry Analyzer
Summary page 1
…Bayer Bayer Healthcare, LLC Corporation Corporation Corporation 510(k) #K960546 #K992257 #K905396 #K972706 Number: Bayer Healthcare, LLC Clinitek Status Premarke…
Bayer Corp.19962
*K992257New Multiples Reagent Strips
Summary page 1
…Bayer Healthcare, LLC Corporation Corporation Corporation 510(k) #K960546 #K992257 #K905396 #K972706 Number: Bayer Healthcare, LLC Clinitek Status Premarket 510(k) Notification =…
Bayer Corp.1999—
*K905396Hemastix Reagent Strips
Summary page 1
…Healthcare, LLC Corporation Corporation Corporation 510(k) #K960546 #K992257 #K905396 #K972706 Number: Bayer Healthcare, LLC Clinitek Status Premarket 510(k) Notification…
Heraeus Kulzer, Inc.1991—
*K972706Clinitek Microalbumin Reagent Strips
Summary page 1
…care, LLC Corporation Corporation Corporation 510(k) #K960546 #K992257 #K905396 #K972706 Number: Bayer Healthcare, LLC Clinitek Status Premarket 510(k) Notification…
Bayer Corp.1997—

Also cleared against K960546: 5 other devices →

What descends from it? (16)

See all 16

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics20096
K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc.20143
K070929Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc.20073
K101673Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, Urs-10Teco Diagnostics20110

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K091216 (Siemens Healthcare Diagnostics, 2009) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K960546.

How does its category compare?

All KQO devices

KQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQO

2in 2015

2007: 12009: 12010: 22011: 22013: 12014: 12015: 2
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KQO

Too few KQO 510(k)s in any year since 2007 to give a median.

Recalls per year · KQO

1in 2021

2010: 72011: 22013: 12016: 12019: 22021: 12026 (partial year): 2
2007high 7 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KQO

12in 2025

2007: 12008: 42009: 92010: 32011: 82012: 152013: 922014: 1062015: 2382016: 3732017: 202018: 252019: 642020: 212021: 132022: 152023: 192024: 202025: 12
2007high 373 (2016) · low 1 (2007)2025

MAUDE reports naming product code KQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—04
20091—09
20102—73
20112—28
20120—015
20131—192
20141—0106
20152—0238
20160—1373
20170—020
20180—025
20190—264
20200—021
20210—113
20220—015
20230—019
20240—020
20250—012
20260—2—

What is it indicated for?

The CLINITEK Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix® brand reagent strips), for testing in the clinical laboratory.

The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.

Indications for use as stated in the FDA summary.

Also cleared against K960546

5 other devices cite the same predicate.

  • K061846Combi SCAN100Analyticon Biotechnologies AG · 2007
  • K061812Combi Scan 500 Urine Test Strip Analyzer, Model A93005Analyticon Biotechnologies AG · 2007
  • K051034Uryxxon 200 Urine AnalyzerMacherey-Nagel GmbH & Co. KG · 2005
  • K032437Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD Test StripsRoche Diagnostics Corp. · 2003
  • K022386Pocketchem UA Aution Sticks 10TAArkray, Inc. · 2002

More from Bayer Healthcare, LLC

50 FDA decisions under this applicant name. See the company

  • K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC · 2018
  • K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015
  • K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014
  • K121190Contour Next Blood Glucose MeterBayer Healthcare, LLC · 2012
  • K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal…Bayer Healthcare, LLC · 2012

Recent decisions in KQO

The KQO category page

  • K141874Uriscan OptimaYd Diagnostics Corp. · 2015
  • K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine ControlACON Laboratories, Inc. · 2015
  • K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration KitSiemens Healthcare Diagnostics · 2014
  • K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips…Arkray, Inc. · 20131 recall
  • K102188Cybow Reader, Models 300 & 720DFI Co., Ltd. · 2011

https://510kreport.com/device/K031947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031947: Bayer Clinitek Status Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031947

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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