Cleared Traditional

K850904 - ALBA DRY BURN DRESSING

K850904 is an FDA 510(k) clearance for ALBA DRY BURN DRESSING, manufactured by Alba Health Care. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K850904 · Alba Health Care · General & Plastic Surgery device
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Apr 1985
Decision
43d
Days
Class 1
Risk

K850904 is an FDA 510(k) clearance for the ALBA DRY BURN DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Alba Health Care (Valdese, US). The FDA issued a Cleared decision on April 17, 1985 after a review of 43 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 Health Care devices

FDA 510(k) Submission Details - K850904

510(k) Number K850904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date April 17, 1985
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

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 44
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K850904.
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
ACU-DERM TRANSPARENT WOUND DRESSING
K842186 · Acme United Corp. · Aug 1984