Cleared Traditional

K822824 - ADHESIVE TAPE/FIRST-BAND

K822824 is an FDA 510(k) clearance for ADHESIVE TAPE/FIRST-BAND, manufactured by Leonard Joseph Co.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K822824 · Leonard Joseph Co. · General & Plastic Surgery device
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Jun 1983
Decision
255d
Days
Class 1
Risk

K822824 is an FDA 510(k) clearance for the ADHESIVE TAPE/FIRST-BAND. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Leonard Joseph Co. (Walker, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 255 days - an extended review 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: 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.

View all Leonard Joseph Co. devices

FDA 510(k) Submission Details - K822824

510(k) Number K822824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1982
Decision Date June 02, 1983
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K822824.
DRESS, SURGICAL ADHESIVE
K833590 · Lectec Corp. · Jan 1984
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833731 · American Medical Disposable, Inc. · Jan 1984
ONE TIME COMPOUND BENZOIN TINCTURE-
K833120 · Acme United Corp. · Dec 1983
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · 3M Company · Feb 1983
CURITY SHETHOSCOPE SECURING PADS
K820872 · The Kendal Co. · Apr 1982
NON-ADHER PADS
K813421 · Abco Dealers, Inc. · Dec 1981