Cleared Traditional

PHOENIX DRAPES WITH MICROBAN (K890917) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K890917 · Phoenix Medical Technology, Inc. · General & Plastic Surgery device
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Aug 1989
Decision
175d
Days
Class 1
Risk

K890917 is an FDA 510(k) clearance for the PHOENIX DRAPES WITH MICROBAN. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Phoenix Medical Technology, Inc. (Fort Worth, US). The FDA issued a Cleared decision on August 17, 1989 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

View all Phoenix Medical Technology, Inc. devices

Submission Details

510(k) Number K890917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1989
Decision Date August 17, 1989
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
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 20
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K890917.
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984