510(k) Report

510(k) · Cleared

Cleared

Precipath (R) IM Normal & Abnormal Immuno. Control

K902220510(k) TraditionalCleared Sep 5, 1990111-day reviewClass I21 CFR 866.5700

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

Boehringer Mannheim Corp. · DGR Whole Human Serum, Antigen, Antiserum, Control

Cleared on Sep 5, 1990 after a 111-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 5, 1990
Review
111 days
Class
Class I
Product code
DGR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K902220Source: FDA 510(k) database · 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.

Planning a device in DGR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All DGR devices

DGR Whole Human Serum, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DGR

FDA has decided no DGR device since 2007.

Median 510(k) review, days · DGR

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

Recalls per year · DGR

No recall names DGR since 2007.

Adverse event reports per year · DGR

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code DGR, 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—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
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 DGR

The DGR category page

  • K961544Qualitrol Igame Controls, Levels 1 and 2Consolidated Technologies, Inc. · 1996
  • K865014Liquichek Immunology Control (Human) Levels I & IIBio-Rad · 1987
  • K790298Radioassay, Control Serum I, II, IiiKallestad Laboratories, Inc. · 1979
  • K781355Ics Normal Control SerumBeckman Instruments, Inc. · 1978

https://510kreport.com/device/K902220 · printed Nov 4, 2026

Cite this page

510(k) Report. “K902220: Precipath (R) IM Normal & Abnormal Immuno. Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902220

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026