Cleared Traditional

Antibacterial Bandage (K201324) - FDA 510(k) Clearance

K201324 · Jiangsu Excellence Medical Supplies Co., Ltd. · General & Plastic Surgery device
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Feb 2021
Decision
263d
Days
-
Risk

K201324 is an FDA 510(k) clearance for the Antibacterial Bandage. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Jiangsu Excellence Medical Supplies Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on February 5, 2021 after a review of 263 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Jiangsu Excellence Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K201324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date February 05, 2021
Days to Decision 263 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 115d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

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