510(k) Report

510(k) · Cleared

Cleared

Boehringer Mannheim Igm Assay

K955908510(k) TraditionalCleared Feb 9, 199642-day reviewClass II21 CFR 866.5550

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

Boehringer Mannheim Corp. · DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control

Cleared on Feb 9, 1996 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 9, 1996
Review
42 days
Class
Class II
Product code
DAO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared1998: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955908 Boehringer Mannheim Igm AssayBoehringer Mannheim Corp. · 1996
  2. Descendant · cites it directly · 0 of its ownK040431 Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp. · 2004 · Recalled
  3. Descendant · cites it directly · 0 of its ownK982382 Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1998 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K040431Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp. · 2004 · cites it directly0descendants
  • K982382Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955908Boehringer Mannheim Igm AssayBoehringer Mannheim Corp.1996—
+1K040431Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp.20041
+1K982382Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc.19981

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
FIG. 1 — Lineage of K955908, 1996–2004Source: 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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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K040431Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp.20040
K982382Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc.19980

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, K040431 (Roche Diagnostics Corp., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DAO devices

DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DAO

FDA has decided no DAO device since 2007.

Median 510(k) review, days · DAO

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

Recalls per year · DAO

No recall names DAO since 2007.

Adverse event reports per year · DAO

4in 2025

2012: 22016: 12017: 12018: 12023: 12024: 32025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code DAO, 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
20110—00
20120—02
20130—00
20140—00
20150—00
20160—01
20170—01
20180—01
20190—00
20200—00
20210—00
20220—00
20230—01
20240—03
20250—04
20260—0—

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in DAO

The DAO category page

  • K040431Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp. · 20041 recall
  • K982639Spife Urine IfeHelena Laboratories · 1998
  • K850586SPQ Test System for Immunoglobulin MApplications Lab · 1985
  • K841992Modification to Acs Coronary GuidingAdvanced Cardiovascular Systems, Inc. · 1984
  • K812487Immunogl. FRCT. of Rabbit Antiser.-IgmDako Corp. · 1981

https://510kreport.com/device/K955908 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955908: Boehringer Mannheim Igm Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955908

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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