Cleared Traditional

K932602 - ADHESIVE BANDAGES

K932602 is an FDA 510(k) clearance for ADHESIVE BANDAGES, manufactured by Aso Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K932602 · Aso Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
73d
Days
Class 1
Risk

K932602 is an FDA 510(k) clearance for the ADHESIVE BANDAGES. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Aso Corp. (Sarasota, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 73 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.

FDA 510(k) Submission Details - K932602

510(k) Number K932602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date August 09, 1993
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
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 184
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K932602.
TISSUE ISOLATION AND RETRIEVAL BAG
K931886 · Advanced Surgical, Inc. · Sep 1993
I.V. START KIT (AHC-50-54954
K924192 · American Healthcare Corp. · Aug 1993
SURESEAL BANDAGE
K922441 · Gainor Medical Europe, Ltd. · Aug 1993
TRANSPARENT ADHESIVE DRESSING
K924794 · Medical Concepts Development, Inc. · Jul 1993
SHAWNEE PRODUCT KIT IV
K923319 · Absentee Shawnee Bandage Group · Jun 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993
K932602 · ADHESIVE BANDAGES
Download PDF FDA Summary Aso Corp.