Cleared Traditional

K831454 - LASTOBAND ADHESIVE BANDAGES

K831454 is an FDA 510(k) clearance for LASTOBAND ADHESIVE BANDAGES, manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K831454 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Oct 1983
Decision
178d
Days
Class 1
Risk

K831454 is an FDA 510(k) clearance for the LASTOBAND ADHESIVE BANDAGES. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K831454

510(k) Number K831454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date October 31, 1983
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
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 K831454.
ELASTIC BREATHABLE OVER-WRAP BANDAGE
K833729 · American Medical Disposable, Inc. · Dec 1983
DERMATEX STERILE FINGER BANDAGE
K833638 · Dermatec, Inc. · Dec 1983
MULTIPLE
K831204 · Derma-Lock Medical Corp. · Nov 1983
TRIANGLE BANDAGE STERILE
K831283 · Pac-Kit Safety Equipment Co. · Aug 1983
UNI-THANE
K831611 · Carapac Systems, Inc. · Jun 1983
MOLNLYCKE MEPORE STERILE SELF-ADHESIVE
K830050 · Lada Intl., Inc. · Jun 1983
K831454 · LASTOBAND ADHESIVE BANDAGES
Download PDF Smith & Nephew, Inc.