510(k) · Cleared

Recalled · Class II · 2026

Olympus AU400 Clinical Chemistry Analyzer

K981743510(k) SpecialCleared Jun 9, 199822-day reviewClass II21 CFR 862.1020Recalls 5

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

Olympus America, Inc. · CKB Acid Phosphatase, Naphthyl Phosphate

Cleared on Jun 9, 1998 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 5 times.

Decided: Jun 9, 1998
Review: 22 days
Class: Class II
Product code: CKB
Recalls: 5
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK981743 Olympus AU400 Clinical Chemistry AnalyzerOlympus America, Inc. · 1998
Descendant · cites it directly · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
Descendant · cites it directly · 0 of its ownK130915 XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent…Jas Diagnostics, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all

K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · cites it directly0descendants
K130915XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJas Diagnostics, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K981743	Olympus AU400 Clinical Chemistry Analyzer	Olympus America, Inc.	1998	—
+1	K140790	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…	Siemens Healthcare Diagnostics	2015	2
+1	K130915	XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack	Jas Diagnostics, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0

FIG. 1 — Lineage of K981743, 1998–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CKB? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K140790	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…	Siemens Healthcare Diagnostics	2015	0
K130915	XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack	Jas Diagnostics, Inc.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 3, 2026	Class II	Z-3332-2026	Software design	Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft…
Apr 30, 2025	Class II	Z-1907-2025	Nonconforming Material/Component	A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is…
Sep 9, 2013	Class II	Z-0153-2014	Nonconforming Material/Component	The 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, 2013	Class II	Z-0152-2014	Nonconforming Material/Component	The 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, 2010	Not classified	Z-0974-2012	Under Investigation by firm	The 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, K140790 (Siemens Healthcare Diagnostics, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CKB devices

CKB Acid Phosphatase, Naphthyl Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKB

FDA has decided no CKB device since 2007.

Median 510(k) review, days · CKB

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

Recalls per year · CKB

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CKB

2in 2021

2007high 2 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	2
2012	—	0	1
2013	—	1	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	2
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981743 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981743: Olympus AU400 Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981743

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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