510(k) Report

FDA applicant

Penn Medical Devices, Inc.

Basking Ridge, NJ8 decisions1986–19870 recalls

FDA records 8 decisions for Penn Medical Devices, Inc. (Basking Ridge, NJ) from 1986 to 1987: 8 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FAD (Stent, Ureteral). 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 Penn Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Penn Medical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Penn Medical Devices, 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 “Penn”

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