Cleared Traditional

K844463 - DERMIDRESS

K844463 is the FDA 510(k) clearance for DERMIDRESS by Kells Medical, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K844463 · Kells Medical, Inc. · General & Plastic Surgery device
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Jan 1985
Decision
49d
Days
Class 1
Risk

K844463 is an FDA 510(k) clearance for the DERMIDRESS. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Kells Medical, Inc. (Burr Ridge, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 49 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 Kells Medical, Inc. devices

Submission Details

510(k) Number K844463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1984
Decision Date January 08, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
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 35
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K844463.
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853820 · Abco Dealers, Inc. · Oct 1985
SHEER ADHESIVE BANDAGES, STERILE
K850529 · Abco Dealers, Inc. · May 1985
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984