510(k) Report

FDA applicant

Sterimed, Inc.

Acworth, GA3 decisions1985–19900 recalls

FDA records 3 decisions for Sterimed, Inc. (Acworth, GA) from 1985 to 1990: 3 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and DRC (Trocar). 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 Sterimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterimed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sterimed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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