510(k) Report

FDA applicant

Coleman Laboratories Corp.

Mchenry, IL2 decisions1980–20140 recalls

FDA records 2 decisions for Coleman Laboratories Corp. (Mchenry, IL) from 1980 to 2014: 2 510(k) clearances. Most are in product codes CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…) and FLN (Monitor, Electric For Gravity Flow Infusion…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Coleman Laboratories”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Coleman Laboratories Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coleman Laboratories Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coleman Laboratories Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides1decision
  • FLNMonitor, Electric For Gravity Flow Infusion Systems1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K133870Fluid Level MonitorColeman Laboratories · 2014
  • K802256Triglycerides DeterminationColeman Laboratories Corp. · 1980

The one decision as Coleman Laboratories Corp. →The one decision as Coleman Laboratories →