510(k) Report

FDA applicant

Barry S. Smith Co.

Sacramento, CA1 decision1989–19890 recalls

FDA records 1 decision for Barry S. Smith Co. (Sacramento, CA) in 1989: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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 Barry S. Smith Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Barry S. Smith Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Barry”

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