510(k) Report

510(k) · Cleared

Cleared

Olympus Cholinesterase Reagent (Catalog Number OSR6114)

K030045510(k) TraditionalCleared Feb 21, 200346-day reviewClass I21 CFR 862.3240

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

Olympus America, Inc. · DIH Colorimetry, Cholinesterase

Cleared on Feb 21, 2003 after a 46-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Feb 21, 2003
Review
46 days
Class
Class I
Product code
DIH
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared200020052010201520202025
  1. This deviceK030045 Olympus Cholinesterase Reagent (Catalog Number OSR6114)Olympus America, Inc. · 2003
  2. Descendant · cites it directly · 0 of its ownK103373 Synchron Systems Cholinesterase (Chex) Model A53722Beckman Coulter, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K103373Synchron Systems Cholinesterase (Chex) Model A53722Beckman Coulter, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030045Olympus Cholinesterase Reagent (Catalog Number OSR6114)Olympus America, Inc.2003—
+1K103373Synchron Systems Cholinesterase (Chex) Model A53722Beckman Coulter, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K030045, 2003–2011Source: 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 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 DIH? 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K103373Synchron Systems Cholinesterase (Chex) Model A53722Beckman Coulter, Inc.20110

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?

  • Of its descendants, K103373 (Beckman Coulter, Inc., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DIH devices

DIH Colorimetry, Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIH

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIH

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

Recalls per year · DIH

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DIH

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code DIH, 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—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—10
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers.

Measurement of serum cholinesterase has been used to assess liver hnction and to investigate the variants of cholinesterase enzyme. It is also usehl in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.

Indications for use as stated in the FDA 510(k) statement.

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 DIH

The DIH category page

  • K103373Synchron Systems Cholinesterase (Chex) Model A53722Beckman Coulter, Inc. · 2011
  • K061093Cholinesterase Gen.2 Test SystemRoche Diagnostics Corp. · 2006
  • K051444Sentinel Cholinesterase LiquidSentinel Ch. Srl · 2005
  • K023992Wiener Lab Colinesterasa AAWiener Laboratories Saic · 2003
  • K013750Advia 1650 Cholinesterase AssayBayer Diagnostics Corp. · 2002

https://510kreport.com/device/K030045 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030045: Olympus Cholinesterase Reagent (Catalog Number OSR6114).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030045

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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