510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Modification to Olympus AU2700 Clinical Chemistry Analyzer

K003721510(k) SpecialCleared Dec 18, 200014-day reviewClass I21 CFR 862.2160Recalls 4

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 Dec 18, 2000 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 4 times.

Decided
Dec 18, 2000
Review
14 days
Class
Class I
Product code
JJE
Recalls
4
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK003721 Modification to Olympus AU2700 Clinical Chemistry AnalyzerOlympus America, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK161837 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry…Beckman Coulter, Inc. · 2016
  3. Descendant · 2 generations on · 0 of its ownK220977 ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry…Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK183375 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd. · 2019

Most influential descendants

Showing 3 of 3 · See all
  • K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc. · 2016 · cites it directly2descendants
  • K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · 2 generations on0descendants
  • K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003721Modification to Olympus AU2700 Clinical Chemistry AnalyzerOlympus America, Inc.2000—
+1K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc.2016—
+2K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.20237
+2K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201910
202310
FIG. 1 — Lineage of K003721, 2000–2023Source: 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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc.20162

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

Recalls of this device

DateClassRecallRoot causeReason
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…
Apr 26, 2013Class IIZ-1430-2013Component design/selectionBeckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received…
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-0976-2012Under Investigation by firmThe recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K161837 (Beckman Coulter, Inc., 2016) has gone furthest, with 2 descendants 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

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

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
  • K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 20136 recalls

https://510kreport.com/device/K003721 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003721: Modification to Olympus AU2700 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/K003721

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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