Cleared Traditional

K881048 - AIRSTRIP* WATERPROOF FIRST AID DRESS/PO...

K881048 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Mar 1988
Decision
10d
Days
-
Risk

K881048 is an FDA 510(k) clearance for the AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on March 21, 1988 after a review of 10 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K881048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1988
Decision Date March 21, 1988
Days to Decision 10 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 219
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K881048.
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K872298 · 3M Company · Apr 1988
DERMATOLOGICAL PATCH
K872926 · Convatec, A Division of E.R. Squibb & Sons · Feb 1988
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987