Cleared Traditional

K896421 - TRANSPARENT FILM I.V. SITE/WOUND DRESSING

K896421 is an FDA 510(k) clearance for TRANSPARENT FILM I.V. SITE/WOUND DRESSING, manufactured by Catalina Biomedical Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K896421 · Catalina Biomedical Corp. · General & Plastic Surgery device
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Jan 1990
Decision
84d
Days
Class 1
Risk

K896421 is an FDA 510(k) clearance for the TRANSPARENT FILM I.V. SITE/WOUND DRESSING. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Catalina Biomedical Corp. (Duarte, US). The FDA issued a Cleared decision on January 31, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5210 - 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 Catalina Biomedical Corp. devices

FDA 510(k) Submission Details - K896421

510(k) Number K896421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1989
Decision Date January 31, 1990
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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 - KMK Device, Intravascular Catheter Securement

All 14
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K896421.
DUODERM TRANSPARENT HYDROCOLLOID DRESSING
K925992 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
IAB ANCHOR
K922103 · Datascope Corp. · Aug 1993
DESERET POSITIONAL SUTURE WING
K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · Ipax, Inc. · Apr 1987
SAFTI-BRACELET
K853418 · Advanced Biosearch Assn. · Sep 1985
ACU-DERM TRANSPARENT IV DRESSING
K842064 · Acme United Corp. · Aug 1984