510(k) Report

FDA applicant

Hercon Laboratories Corp.

So. Plainfield, NJ3 decisions1986–19870 recalls

FDA records 3 decisions for Hercon Laboratories Corp. (So. Plainfield, NJ) from 1986 to 1987: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KGX (Tape And Bandage, Adhesive). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Hercon Laboratories Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hercon 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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