Cleared Traditional

K922959 - ISOPORE TAPE

K922959 is an FDA 510(k) clearance for ISOPORE TAPE, manufactured by Lectec Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K922959 · Lectec Corp. · General & Plastic Surgery device
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Sep 1992
Decision
85d
Days
Class 1
Risk

K922959 is an FDA 510(k) clearance for the ISOPORE TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 85 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 Lectec Corp. devices

FDA 510(k) Submission Details - K922959

510(k) Number K922959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date September 11, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 77
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K922959.
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
LUEKOFLEX SURGICAL TAPE
K923404 · Beiersdorf, Inc. · Sep 1992
DEROYAL EYE DRESSING
K923300 · Deroyal Industries, Inc. · Sep 1992
DUODERM SUSTAINED COMPRESSION BANDAGE
K920675 · Convatec, A Division of E.R. Squibb & Sons · Aug 1992