510(k) Report

FDA applicant

Lake Medical Products, Inc.

Maryland Heights, MO15 decisions1987–19950 recalls

FDA records 15 decisions for Lake Medical Products, Inc. (Maryland Heights, MO) from 1987 to 1995: 15 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and KOD (Catheter, Urological). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Lake Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lake Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lake Medical Products, 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 “Lake”

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