Cleared Traditional

K890748 - ALLEVYN TRACHEOSTOMY DRESSING

K890748 is an FDA 510(k) clearance for ALLEVYN TRACHEOSTOMY DRESSING, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K890748 · Smith & Nephew United, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Mar 1989
Decision
23d
Days
Class 1
Risk

K890748 is an FDA 510(k) clearance for the ALLEVYN TRACHEOSTOMY DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on March 8, 1989 after a review of 23 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.

FDA 510(k) Submission Details - K890748

510(k) Number K890748 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 13, 1989
Decision Date March 08, 1989
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 107
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K890748.
FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
K885325 · Frastec Wound Care Products, Inc. · Apr 1989
MODIFIED LABELING FOR POLYDERM WBC(TM)
K890940 · Laivan Corp. · Apr 1989
POLYMER ADHESIVE BANDAGE
K883391 · Marion Laboratories, Inc. · Mar 1989
REPLICARE (ADDITIONAL CLAIMS)
K883849 · United Medical · Feb 1989
TECNOL VARIABLE TENSION BANDAGE
K884440 · Tecnol New Jersey Wound Care, Inc. · Jan 1989
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
K881426 · Laboratoire Pan-Pra · Nov 1988
K890748 · ALLEVYN TRACHEOSTOMY DRESSING
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