510(k) Report

FDA applicant

Tri/Bor Medical, Inc.

Westtown, NY5 decisions1991–19910 recalls

FDA records 5 decisions for Tri/Bor Medical, Inc. (Westtown, NY) in 1991: 5 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BYG (Mask, Oxygen). 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, anesthesiology panel, where it files most

How often FDA has decided Tri/Bor Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tri/Bor Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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