Cleared Traditional

K922228 - 2ND SKIN STERILE ADHESIVE STRIP

K922228 is an FDA 510(k) clearance for 2ND SKIN STERILE ADHESIVE STRIP, manufactured by Spenco Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K922228 · Spenco Medical Corp. · General & Plastic Surgery device
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Dec 1992
Decision
213d
Days
Class 1
Risk

K922228 is an FDA 510(k) clearance for the 2ND SKIN STERILE ADHESIVE STRIP. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on December 11, 1992 after a review of 213 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 Spenco Medical Corp. devices

FDA 510(k) Submission Details - K922228

510(k) Number K922228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 12, 1992
Decision Date December 11, 1992
Days to Decision 213 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 115d · This submission: 213d
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 90
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K922228.
TISSUE ISOLATION AND RETRIEVAL BAG
K931886 · Advanced Surgical, Inc. · Sep 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · Lectec Corp. · Apr 1993
STRAPPAL
K922897 · Smith & Nephew United, Inc. · Sep 1992
ISOPORE TAPE
K922959 · Lectec Corp. · Sep 1992
LUEKOFLEX SURGICAL TAPE
K923404 · Beiersdorf, Inc. · Sep 1992