Cleared Traditional

LT Antibacterial Alginate with Silver Dressing (K192478) - FDA 510(k) Clearance

K192478 · Zhejiang Longterm Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
281d
Days
-
Risk

K192478 is an FDA 510(k) clearance for the LT Antibacterial Alginate with Silver Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Zhejiang Longterm Medical Technology Co., Ltd. (Deqing, CN). The FDA issued a Cleared decision on June 17, 2020 after a review of 281 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 Zhejiang Longterm Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K192478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2019
Decision Date June 17, 2020
Days to Decision 281 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
166d slower than avg
Panel avg: 115d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Zhenjiang Longterm Medical Technology Co., Ltd.
Claudia Zsang

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

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K192478.
MEBO Wound Dressing
K193439 · Mebo Life Science, Inc. · Sep 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835 · 3M Company · Sep 2020
HaloGUARD Protective Disc with CHG
K200641 · Attwill Medical Solutions · Sep 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
K191819 · Winner Medical Co., Ltd. · May 2020
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
K192463 · Winner Medical Co., Ltd. · May 2020
PuraDERM Gel
K193085 · 3-D Matrix, Inc. · May 2020