510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Olympus AU600 Clinical Chemistry Analyzer

K961274510(k) TraditionalCleared Jul 5, 199694-day reviewClass I21 CFR 862.2160Recalls 7

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

Olympus America, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on Jul 5, 1996 after a 94-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled 7 times.

Decided
Jul 5, 1996
Review
94 days
Class
Class I
Product code
JJE
Recalls
7
Predicates
0

8 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2008: 4 descendants cleared2009: 1 descendant cleared2007: 1 descendant cleared2024: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961274 Olympus AU600 Clinical Chemistry AnalyzerOlympus America, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK072140 S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc. · 2008
  3. Descendant · cites it directly · 1 of its ownK063804 Olympus Triglyceride Test SystemOlympus America, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK232404 CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A · 2024
  5. Descendant · 2 generations on · 0 of its ownK120369 Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc. · 2012
  6. Descendant · cites it directly · 0 of its ownK083040 S-Test C-Reactive Protein (CRP)Alfa Wassermann Diagnostic Technologies, Inc. · 2009

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007: 12008: 42009: 12012: 12024: 1
2007high 4 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc. · 2008 · cites it directly1descendant
  • K063804Olympus Triglyceride Test SystemOlympus America, Inc. · 2007 · cites it directly1descendant
  • K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A · 2024 · 2 generations on0descendants
  • K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc. · 2012 · 2 generations on0descendants
  • K083040S-Test C-Reactive Protein (CRP)Alfa Wassermann Diagnostic Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961274Olympus AU600 Clinical Chemistry AnalyzerOlympus America, Inc.1996—
+1K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc.2008—
+1K063804Olympus Triglyceride Test SystemOlympus America, Inc.20071
+2K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A2024—
+2K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc.2012—
+1K083040S-Test C-Reactive Protein (CRP)Alfa Wassermann Diagnostic Technologies, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200840
200910
201210
202410
FIG. 1 — Lineage of K961274, 1996–2024Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJE? 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc.20081
K063804Olympus Triglyceride Test SystemOlympus America, Inc.20071
K083040S-Test C-Reactive Protein (CRP)Alfa Wassermann Diagnostic Technologies, Inc.20090
K072143S40 Clinical Analyzer, S Test AlbAlfa Wassermann Diagnostic Technologies, Inc.20080
K072142S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test AstAlfa Wassermann Diagnostic Technologies, Inc.20080
K072141S40 Clinical Analyzer, S Test IP, S Test UAAlfa Wassermann Diagnostic Technologies, Inc.20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 30, 2025Class IIZ-1908-2025Nonconforming Material/ComponentSample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results…
Feb 13, 2017Class IIZ-1704-2017Process controlBeckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
Jul 30, 2015Class IIZ-2309-2016Nonconforming Material/ComponentBeckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the…
Sep 9, 2013Class IIZ-0153-2014Nonconforming Material/ComponentThe recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air…
Sep 9, 2013Class IIZ-0152-2014Nonconforming Material/ComponentThe recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air…
Jul 12, 2010Not classifiedZ-0974-2012Under Investigation by firmThe recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.
Jul 12, 2010Not classifiedZ-0975-2012Under Investigation by firmThe recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K072140 (Alfa Wassermann Diagnostic Technologies, Inc., 2008) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJE

1in 2019

2008: 12011: 22012: 12013: 12014: 32019: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2014: 224 days median
2007high 224 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJE

6in 2025

2007: 202008: 202009: 142010: 322011: 252012: 162013: 212014: 142015: 152016: 92017: 182018: 172019: 72020: 72021: 62023: 122024: 62025: 62026 (partial year): 5
2007high 32 (2010) · low 0 (2022)2026

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

Adverse event reports per year · JJE

4,400in 2025

2007: 2,1812008: 2,1592009: 3,4402010: 3,2732011: 11,6062012: 3,7072013: 2,4892014: 2,8412015: 2,7932016: 2,5802017: 1,8692018: 4,5902019: 3,9482020: 3,9862021: 3,9202022: 3,9982023: 3,7832024: 4,2212025: 4,400
2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, 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
20070—202,181
20081—202,159
20090—143,440
20100—323,273
20112—2511,606
20121—163,707
20131—212,489
20143224142,841
20150—152,793
20160—92,580
20170—181,869
20180—174,590
20191—73,948
20200—73,986
20210—63,920
20220—03,998
20230—123,783
20240—64,221
20250—64,400
20260—5—

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

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Recent decisions in JJE

The JJE category page

  • K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd. · 2019
  • K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, CarCarolina Liquid Chemistries Corp. · 2014
  • K130915XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJas Diagnostics, Inc. · 2014
  • K131554RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) ReagentRandox Laboratories, Ltd. · 20143 recalls
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https://510kreport.com/device/K961274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961274: Olympus AU600 Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961274

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026