Cleared Traditional

K023540 - SNAP KOVER, MODEL 01-2020

Also marketed or referenced as:
SNAP KAPS, MODEL 03-KP09

K023540 is an FDA 510(k) clearance for SNAP KOVER, manufactured by Valumed. The device is a Class 2 General Hospital device with product code MMP cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K023540 · Valumed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
105d
Days
Class 2
Risk

K023540 is an FDA 510(k) clearance for the SNAP KOVER, MODEL 01-2020. Classified as Cover, Barrier, Protective (product code MMP), Class II - Special Controls.

Submitted by Valumed (Niceville, US). The FDA issued a Cleared decision on February 4, 2003 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Valumed devices

FDA 510(k) Submission Details - K023540

510(k) Number K023540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2002
Decision Date February 04, 2003
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMP Device Classification - Class 2, Special Controls

Product Code MMP Cover, Barrier, Protective
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MMP Cover, Barrier, Protective

Devices cleared under the same product code (MMP) and FDA review panel - the closest regulatory comparables to K023540.
MEDLINE BAND BAGS AND EQUIPMENT COVERS
K032065 · Medline Industries, Inc. · Sep 2003
ULTRASOUND SYSTEMS DRAPE
K970885 · Protek Medical Products, Inc. · Sep 1997
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
K962288 · Pinnacle Products, Inc. · Jan 1997
EQUIPMENT COVERS
K961699 · United States Surgical, A Division of Tyco Healthc · Aug 1996