Cleared Traditional

K852091 - ALBA DRY BURN PAD

K852091 is the FDA 510(k) clearance for ALBA DRY BURN PAD by Alba-Waldensian, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K852091 · Alba-Waldensian, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
31d
Days
Class 1
Risk

K852091 is an FDA 510(k) clearance for the ALBA DRY BURN PAD. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Alba-Waldensian, Inc. (Valdese, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Alba-Waldensian, Inc. devices

Submission Details

510(k) Number K852091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date June 13, 1985
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 37
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K852091.
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851382 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
BLISTERFILM TRANSPARENT DRESSING
K851383 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
HYPAFIX POST OPERATIVE DRESSING
K850282 · Smith & Nephew, Inc. · May 1985
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
K843139 · Chesebrough-Pond'S U.S.A. Co. · Nov 1984
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
K843140 · Chesebrough-Pond'S U.S.A. Co. · Nov 1984