Cleared Traditional

Medline Burn and Wound Dressing (K173911) - FDA 510(k) Clearance

K173911 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
209d
Days
-
Risk

K173911 is an FDA 510(k) clearance for the Medline Burn and Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on July 19, 2018 after a review of 209 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K173911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date July 19, 2018
Days to Decision 209 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
94d slower than avg
Panel avg: 115d · This submission: 209d
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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K172554 · Huizhou Foryou Medical Devices Co., Ltd. · May 2018