Cleared Traditional

K022587 - MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (FDA 510(k) Clearance)

K022587 · Medtrade Products , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
382d
Days
-
Risk

K022587 is an FDA 510(k) clearance for the MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on August 22, 2003 after a review of 382 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Medtrade Products , Ltd. devices

Submission Details

510(k) Number K022587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date August 22, 2003
Days to Decision 382 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
268d slower than avg
Panel avg: 114d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -