510(k) Report

FDA applicant

Stephenson Industries, Inc.

Farmingdale, NJ4 decisions1985–19970 recalls

FDA records 4 decisions for Stephenson Industries, Inc. (Farmingdale, NJ) from 1985 to 1997: 4 510(k) clearances. Most are in product codes KPJ (Chamber, Oxygen, Topical, Extremity) and BTL (Ventilator, Emergency, Powered (Resuscitator)). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Stephenson Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stephenson Industries, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report