Cleared Traditional

K945832 - BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS

K945832 is an FDA 510(k) clearance for BRADY MEDICAL PRODUCTS TRANSCORBENT AND..., 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 92-day FDA review.

K945832 · Brady Medical Products Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
92d
Days
Class 1
Risk

K945832 is an FDA 510(k) clearance for the BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS. 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 March 1, 1995 after a review of 92 days - within the typical 510(k) review window.

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 - K945832

510(k) Number K945832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1994
Decision Date March 01, 1995
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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 K945832.
HYDROGEL SKIN DRESSING
K962352 · North American Sterilization & Packaging Co. · Aug 1996
AQUAFLO HYDROGEL WOUND DRESSING & PACKER
K952945 · Sherwood Medical Co. · Aug 1995
CURAGEL HYDROGEL WOUND DRESSING
K950412 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1995
INTRASITE
K942748 · Smith & Nephew United, Inc. · Jun 1994
ALLEVYN ISLAND WOUND DRESSING
K935705 · Smith & Nephew United, Inc. · Feb 1994
NU-GEL ISLAND WOUND DRESSING
K932336 · Johnson & Johnson Medical, Inc. · Feb 1994