Cleared Traditional

anti-bacterial bandage (K200821) - FDA 510(k) Clearance

K200821 · Planet (Suzhou) Medical Products Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
203d
Days
-
Risk

K200821 is an FDA 510(k) clearance for the anti-bacterial bandage. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Planet (Suzhou) Medical Products Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 19, 2020 after a review of 203 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 Planet (Suzhou) Medical Products Co., Ltd. devices

Submission Details

510(k) Number K200821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2020
Decision Date October 19, 2020
Days to Decision 203 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
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Linkhope Medical Technology, Inc.
Van Lee

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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