510(k) Report

510(k) · Cleared

Cleared

Olympus Igm Immunoturbidimetric Reagent

K950900510(k) TraditionalCleared Mar 27, 199527-day reviewClass II21 CFR 866.5510

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

Olympus America, Inc. · CFQ Radioimmunoassay, Immunoglobulins (G, A, M)

Cleared on Mar 27, 1995 after a 27-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 27, 1995
Review
27 days
Class
Class II
Product code
CFQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950900 Olympus Igm Immunoturbidimetric ReagentOlympus America, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK073487 Olympus Igm ReagentOlympus America, Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K073487Olympus Igm ReagentOlympus America, Inc. · 2008 · cites it directly1descendant
  • K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950900Olympus Igm Immunoturbidimetric ReagentOlympus America, Inc.1995—
+1K073487Olympus Igm ReagentOlympus America, Inc.20081
+2K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
202010
FIG. 1 — Lineage of K950900, 1995–2020Source: 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.

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  • 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K073487Olympus Igm ReagentOlympus America, Inc.20081

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, K073487 (Olympus America, Inc., 2008) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CFQ devices

CFQ Radioimmunoassay, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFQ

FDA has decided no CFQ device since 2007.

Median 510(k) review, days · CFQ

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

Recalls per year · CFQ

No recall names CFQ since 2007.

Adverse event reports per year · CFQ

1in 2018

2008: 12009: 12012: 32016: 12018: 1
2007high 3 (2012) · low 0 (2007)2025

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

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 CFQ

The CFQ category page

  • K981786Iga Minineph AntiserumThe Binding Site, Ltd. · 1999
  • K990552Immunoglobulin a Test SystemDade Behring, Inc. · 1999
  • K990551Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
  • K990553Igm Flex Reagent CartridgeDade Behring, Inc. · 1999
  • K951013Olympus Igg Immunoturbidimetric ReagentOlympus America, Inc. · 1995

https://510kreport.com/device/K950900 · printed Nov 3, 2026

Cite this page

510(k) Report. “K950900: Olympus Igm Immunoturbidimetric Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K950900

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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