Cleared Traditional

BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING (K935848) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K935848 · Brady Medical Products Co. · General & Plastic Surgery device
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Feb 1994
Decision
69d
Days
Class 1
Risk

K935848 is an FDA 510(k) clearance for the BRADY MEDICAL PRODUCTS TRANSORB 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 February 15, 1994 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brady Medical Products Co. devices

Submission Details

510(k) Number K935848 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 08, 1993
Decision Date February 15, 1994
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.