Cleared Traditional

K923235 - BIOCLUSIVE MVP TRANSPARENT DRESSING

K923235 is an FDA 510(k) clearance for BIOCLUSIVE MVP TRANSPARENT DRESSING, manufactured by Johnson & Johnson Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K923235 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
315d
Days
Class 1
Risk

K923235 is an FDA 510(k) clearance for the BIOCLUSIVE MVP TRANSPARENT DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K923235

510(k) Number K923235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date May 12, 1993
Days to Decision 315 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
200d slower than avg
Panel avg: 115d · This submission: 315d
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 K923235.
ADHESIVE BANDAGES
K932602 · Aso Corp. · Aug 1993
TRANSPARENT ADHESIVE DRESSING
K924794 · Medical Concepts Development, Inc. · Jul 1993
SHAWNEE PRODUCT KIT IV
K923319 · Absentee Shawnee Bandage Group · Jun 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · Lectec Corp. · Apr 1993
INGROWN TOENAIL PAD
K923662 · Many Bee Co. · Apr 1993
MEDICOTEST SKIN FIX
K926264 · Medicotest, Inc. · Apr 1993
K923235 · BIOCLUSIVE MVP TRANSPARENT DRESSING
Download PDF FDA Summary Johnson & Johnson Med…