Cleared Traditional

K964142 - MEDLINE DISPOSABLE SURGICAL DRAPES AND ...

K964142 is the FDA 510(k) clearance for MEDLINE DISPOSABLE SURGICAL DRAPES AND ... by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K964142 · Medline Industries, Inc. · General Hospital
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Feb 1997
Decision
132d
Days
Class 2
Risk

K964142 is an FDA 510(k) clearance for the MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 25, 1997 after a review of 132 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K964142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date February 25, 1997
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 129d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
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 - KKX Drape, Surgical

All 145
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K964142.
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647 · Customed, Inc. · Jan 1998
CONVERTORS SMS DRAPES
K970554 · Allegiance Healthcare Corp. · May 1997
EYE TRAY
K970722 · Trinity Laboratories, Inc. · Mar 1997
CONVERTORS DRAPE MATERIAL
K964125 · Allegiance Healthcare Corp. · Dec 1996
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
K962205 · Medline Industries, Inc. · Nov 1996
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · Deroyal Industries, Inc. · Dec 1995