510(k) Report

510(k) · Cleared

Cleared

Olympus CK-MB Reagent

K971817510(k) TraditionalCleared Jun 11, 199726-day reviewClass I21 CFR 862.1210

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

Olympus America, Inc. · JLB Atp And Creatine Kinase (Enzymatic), Creatine

Cleared on Jun 11, 1997 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Jun 11, 1997
Review
26 days
Class
Class I
Product code
JLB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971817 Olympus CK-MB ReagentOlympus America, Inc. · 1997
  2. Descendant · cites it directly · 0 of its ownK070835 Olympus CK-MB ReagentOlympus Life & Material Science Europa GmbH (Irish · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K070835Olympus CK-MB ReagentOlympus Life & Material Science Europa GmbH (Irish · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971817Olympus CK-MB ReagentOlympus America, Inc.1997—
+1K070835Olympus CK-MB ReagentOlympus Life & Material Science Europa GmbH (Irish2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K971817, 1997–2007Source: 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 JLB? 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
K070835Olympus CK-MB ReagentOlympus Life & Material Science Europa GmbH (Irish20070

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, K070835 (Olympus Life & Material Science Europa GmbH (Irish, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JLB devices

JLB Atp And Creatine Kinase (Enzymatic), Creatine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JLB

FDA has decided no JLB device since 2007.

Median 510(k) review, days · JLB

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

Recalls per year · JLB

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JLB

2in 2020

2010: 32011: 502012: 732013: 152014: 12020: 2
2007high 73 (2012) · low 0 (2007)2025

MAUDE reports naming product code JLB, 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—20
20090—00
20100—03
20110—050
20120—073
20130—015
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-§1B isoenzyme in human serum on Olympus analyzers.

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

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 JLB

The JLB category page

  • K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc. · 19992 recalls
  • K782156Unitest Creatine KinaseBoehringer Mannheim Corp. · 1979

https://510kreport.com/device/K971817 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971817: Olympus CK-MB Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971817

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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