510(k) Report

FDA applicant

Omp Laboratories, Inc.

Mchenry, IL2 decisions1976–19780 recalls

FDA records 2 decisions for Omp Laboratories, Inc. (Mchenry, IL) from 1976 to 1978: 2 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and CBA (Monitor, Air Embolism, Ultrasonic). No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Omp Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DQOCatheter, Intravascular, Diagnostic1decision
  • CBAMonitor, Air Embolism, Ultrasonic1decision

What has FDA decided for it lately?

  • K780703Cuff PacerOmp Laboratories, Inc. · 1978
  • K760402Syringe Set, 3-Way ThermodilutinOmp Laboratories, Inc. · 1976

All 2 as Omp Laboratories, Inc. →