510(k) Report

FDA applicant

Dia-Stron, Ltd.

Broomall, PA1 decision1992–19920 recalls

FDA records 1 decision for Dia-Stron, Ltd. (Broomall, PA) in 1992: 1 510(k) clearance. All are in product code FTI (Lamp, Endoscope, Incandescent). 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 Dia-Stron, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dia-Stron, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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