510(k) Report

FDA applicant

Concord Laboratories, Inc.

Mchenry, IL42 decisions1976–19890 recalls

FDA records 42 decisions for Concord Laboratories, Inc. (Mchenry, IL) from 1976 to 1989: 42 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FCM (Tray, Catheterization, Sterile Urethral, With…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Concord Laboratories, Inc.’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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Other applicant names beginning “Concord”

FDA records each applicant name separately; these may or may not be the same firm.