510(k) Report

510(k) · Cleared

Cleared

Enzymun Test (R) Insulin

K901135510(k) TraditionalCleared Apr 3, 199022-day reviewClass I21 CFR 862.1405

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

Boehringer Mannheim Corp. · CFP Radioimmunoassay, Immunoreactive Insulin

Cleared on Apr 3, 1990 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 3, 1990
Review
22 days
Class
Class I
Product code
CFP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K901135Source: 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 CFP? 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 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 CFP devices

CFP Radioimmunoassay, Immunoreactive Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFP

FDA has decided no CFP device since 2007.

Median 510(k) review, days · CFP

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

Recalls per year · CFP

1in 2024

2007: 12012: 22023: 12024: 1
2007high 2 (2012) · low 0 (2008)2026

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

Adverse event reports per year · CFP

17in 2025

2010: 12011: 22012: 82013: 12014: 22015: 12016: 32017: 42018: 42019: 92020: 62021: 102022: 72023: 102024: 72025: 17
2007high 17 (2025) · low 0 (2007)2025

MAUDE reports naming product code CFP, 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—10
20080—00
20090—00
20100—01
20110—02
20120—28
20130—01
20140—02
20150—01
20160—03
20170—04
20180—04
20190—09
20200—06
20210—010
20220—07
20230—110
20240—17
20250—017
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 CFP

The CFP category page

  • K963911Alpco/Mercodia Insulin ElisaAmerican Laboratory Products Co., Ltd. · 1996
  • K953084Access Ultrasensitive Insulin AssayBio-Rad Laboratories, Inc. · 19952 recalls
  • K920109Imx InsulinAbbott Laboratories · 1992
  • K914820DSL Insulin Ria (DSL 1600)Diagnostic Systems Laboratories, Inc. · 1992
  • K903628Aia-Pack IriTosoh Corp. · 1990

https://510kreport.com/device/K901135 · printed Nov 5, 2026

Cite this page

510(k) Report. “K901135: Enzymun Test (R) Insulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K901135

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