Cleared Traditional

K813421 - NON-ADHER PADS

K813421 is the FDA 510(k) clearance for NON-ADHER PADS by Abco Dealers, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K813421 · Abco Dealers, Inc. · General & Plastic Surgery device
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Dec 1981
Decision
11d
Days
Class 1
Risk

K813421 is an FDA 510(k) clearance for the NON-ADHER PADS. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1981 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K813421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date December 18, 1981
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 59
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K813421.
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · 3M Company · Feb 1983
CURITY SHETHOSCOPE SECURING PADS
K820872 · The Kendal Co. · Apr 1982
ETHICON* SKIN CLOSURE TAPE
K813124 · Ethicon, Inc. · Dec 1981
DESERET CATHETER DRESSING
K812073 · Warner-Lambert Co. · Oct 1981
TEGADERM TRANSPARENT DRESSING
K811291 · 3M Company · Jun 1981