510(k) Report

FDA applicant

Promedical Products Co., Ltd.

Starkville, MS6 decisions2004–20090 recalls

FDA records 6 decisions for Promedical Products Co., Ltd. (Starkville, MS) from 2004 to 2009: 6 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Promedical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 22009: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Promedical Products Co., Ltd.’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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Other applicant names beginning “Promedical”

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