510(k) Report

FDA applicant

Amsia Intl., Inc.

Pomona, CA2 decisions1989–19960 recalls

FDA records 2 decisions for Amsia Intl., Inc. (Pomona, CA) from 1989 to 1996: 2 510(k) clearances. Most are in product codes FLK (Thermometer, Clinical Mercury) and LYY (Latex Patient Examination Glove). 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 hospital panel, where it files most

How often FDA has decided Amsia Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amsia Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amsia Intl., 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?

  • FLKThermometer, Clinical Mercury1decision
  • LYYLatex Patient Examination Glove1decision

What has FDA decided for it lately?

  • K960185Amsino Clinical ThermometerAmsia Intl., Inc. · 1996
  • K891866Rubber Latex Patient Examination GlovesAmsia Intl., Inc. · 1989

All 2 as Amsia Intl., Inc. →