510(k) Report

FDA applicant

Fvtnks

Indianapolis, IN4 decisions1994–19950 recalls

FDA records 4 decisions for Fvtnks (Indianapolis, IN) from 1994 to 1995: 4 510(k) clearances. Most are in product codes BYG (Mask, Oxygen) and BSJ (Mask, Gas, Anesthetic). 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 Fvtnks’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fvtnks since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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