Cleared Traditional

K894898 - 2ND SKIN NON-STICK MOIST BURN PADS

K894898 · Spenco Medical Corp. · General & Plastic Surgery device
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Aug 1989
Decision
22d
Days
-
Risk

K894898 is an FDA 510(k) clearance for the 2ND SKIN NON-STICK MOIST BURN PADS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on August 23, 1989 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Spenco Medical Corp. devices

Submission Details

510(k) Number K894898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date August 23, 1989
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 224
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K894898.
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K891870 · Smith & Nephew United, Inc. · Aug 1989
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
K885279 · Beiersdorf, Inc. · Jun 1989
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989