Cleared Traditional

K914912 - PROMEON 63B SURGICAL TAPE

K914912 is an FDA 510(k) clearance for PROMEON 63B SURGICAL TAPE, manufactured by Promeon. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K914912 · Promeon · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
33d
Days
Class 1
Risk

K914912 is an FDA 510(k) clearance for the PROMEON 63B SURGICAL TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Promeon (Brooklyn Center, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 33 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 Promeon devices

FDA 510(k) Submission Details - K914912

510(k) Number K914912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1991
Decision Date December 04, 1991
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K914912.
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
CANN-HOLD
K915057 · O.R. Concepts, Inc. · Mar 1992
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
K914315 · Medical Dynamics, Inc. · Mar 1992
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
K912518 · Convatec, A Division of E.R. Squibb & Sons · Sep 1991
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K912550 · Convatec, A Division of E.R. Squibb & Sons · Aug 1991
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K912520 · 3M Health Care, Ltd. · Jul 1991