Cleared Traditional

K924249 - DERMASSIST TRANSPARENT SITE DRESSING

K924249 is an FDA 510(k) clearance for DERMASSIST TRANSPARENT SITE DRESSING, manufactured by Wilshire Medical Products. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K924249 · Wilshire Medical Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
163d
Days
Class 1
Risk

K924249 is an FDA 510(k) clearance for the DERMASSIST TRANSPARENT SITE DRESSING. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Wilshire Medical Products (Dallas, US). The FDA issued a Cleared decision on February 3, 1993 after a review of 163 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Wilshire Medical Products devices

FDA 510(k) Submission Details - K924249

510(k) Number K924249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date February 03, 1993
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
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 K924249.
CENTERMARK SECURING WINGS
K940127 · Menlo Care, Inc. · Feb 1994
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