510(k) Report

FDA applicant

American Sterilizer Co.

Erie, PA36 decisions1977–19942 recalls

FDA records 36 decisions for American Sterilizer Co. (Erie, PA) from 1977 to 1994: 36 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRG (Wrap, Sterilization). 2 recalls are 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 American Sterilizer Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Sterilizer Co. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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