510(k) Report

FDA applicant

Safetec of America, Inc.

Buffalo, NY4 decisions1995–19960 recalls

FDA records 4 decisions for Safetec of America, Inc. (Buffalo, NY) from 1995 to 1996: 4 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYA (Gown, 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 Safetec of America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safetec of America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FXXMask, Surgical2decisions
  • FYAGown, Surgical1decision
  • CBPValve, Non-Rebreathing1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K952962EZ-Personal Protection KitSafetec of America, Inc. · 19951cites it

What has FDA decided for it lately?

  • K960073EZ-Personal Protection Kit with Spill Clean UPSafetec of America, Inc. · 1996
  • K960048EZ-Personal Protection Kit with Spill Clean UP - PlusSafetec of America, Inc. · 1996
  • K953461CPR Mask & Related Family KitsSafetec of America, Inc. · 1996
  • K952962EZ-Personal Protection KitSafetec of America, Inc. · 1995

All 4 as Safetec of America, Inc. →