Cleared Traditional

K024054 - XYLOS XCELL ANTIMICROBIAL DRESSING

K024054 · Xylos Corporation · General & Plastic Surgery device
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Mar 2003
Decision
88d
Days
-
Risk

K024054 is an FDA 510(k) clearance for the XYLOS XCELL ANTIMICROBIAL DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Xylos Corporation (Washington, US). The FDA issued a Cleared decision on March 7, 2003 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K024054

510(k) Number K024054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2002
Decision Date March 07, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

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

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 98
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K024054.
TENDERWET ACTIVE
K040517 · Medline Industries, Inc. · Mar 2004
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · Medtrade Products , Ltd. · Aug 2003
SINCLAIR WOUND AND SKIN EMULSION
K024367 · Sinclair Pharmaceuticals, Ltd. · Jul 2003
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
K022584 · Cardiotech Intl. · Dec 2002
COLLATEK HYDROGEL
K022995 · Biocore Medical Technologies, Inc. · Dec 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
K013525 · Coloplast Corp. · Oct 2002