510(k) Report

FDA applicant

Zefon Medical Products

Ocala, FL4 decisions1993–19940 recalls

FDA records 4 decisions for Zefon Medical Products (Ocala, FL) from 1993 to 1994: 4 510(k) clearances. Most are in product codes CAI (Circuit, Breathing (W Connector, Adaptor, Y…) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). 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 Zefon Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zefon Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Zefon”

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