Cleared Traditional

K922666 - TRANSORB(TM) ULCER & WOUND DRESSING

K922666 is an FDA 510(k) clearance for TRANSORB(TM) ULCER & WOUND DRESSING, manufactured by Brady Medical Products Co.. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K922666 · Brady Medical Products Co. · General & Plastic Surgery device
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Nov 1992
Decision
179d
Days
Class 1
Risk

K922666 is an FDA 510(k) clearance for the TRANSORB(TM) ULCER & WOUND DRESSING. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Brady Medical Products Co. (Milwaukee, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 179 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - the FDA general and plastic surgery device framework. 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 Brady Medical Products Co. devices

FDA 510(k) Submission Details - K922666

510(k) Number K922666 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 28, 1992
Decision Date November 23, 1992
Days to Decision 179 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 115d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

NAE Device Classification - Class 1, General Controls

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic

All 19
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K922666.
NU-GEL ISLAND WOUND DRESSING
K932336 · Johnson & Johnson Medical, Inc. · Feb 1994
DUODERM HYDROCOLLOID GEL
K931618 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
INTRASITE GEL
K926508 · Smith & Nephew United, Inc. · Jul 1993
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357 · Medtronic Vascular · May 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359 · Medtronic Vascular · May 1992
DEROYAL HYDROGEL DRESSING
K915182 · Deroyal Industries, Inc. · Apr 1992