510(k) Report

FDA applicant

Op-Co Medical Products, Ltd.

New York City, NY3 decisions1991–19950 recalls

FDA records 3 decisions for Op-Co Medical Products, Ltd. (New York City, NY) from 1991 to 1995: 3 510(k) clearances. All are in product code KMK (Device, Intravascular Catheter Securement). 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 Op-Co Medical Products, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Op-Co Medical Products, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Op-Co Medical Products, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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