510(k) Report

FDA applicant

Allmed Medical Products Co., Ltd.

Zhijiang, CN4 decisions2021–20230 recalls

FDA records 4 decisions for Allmed Medical Products Co., Ltd. (Zhijiang, CN) from 2021 to 2023: 4 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 254 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Allmed Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 32023: 1
2021high 3 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Allmed Medical Products Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Allmed Medical 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 “Allmed”

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