Cleared Traditional

PARALLEL (K954007) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K954007 · Johnson & Johnson Consumer Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
89d
Days
Class 1
Risk

K954007 is an FDA 510(k) clearance for the PARALLEL. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Johnson & Johnson Consumer Products, Inc. (Skillman, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 89 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 Johnson & Johnson Consumer Products, Inc. devices

Submission Details

510(k) Number K954007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date November 22, 1995
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 186
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K954007.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984