Cleared Traditional

Antibacterial bandage (K221570) - FDA 510(k) Clearance

K221570 · Allmed Medical Products Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
486d
Days
-
Risk

K221570 is an FDA 510(k) clearance for the Antibacterial bandage. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Allmed Medical Products Co., Ltd. (Zhijiang, CN). The FDA issued a Cleared decision on September 29, 2023 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Allmed Medical Products Co., Ltd. devices

Submission Details

510(k) Number K221570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2022
Decision Date September 29, 2023
Days to Decision 486 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
371d slower than avg
Panel avg: 115d · This submission: 486d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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