Cleared Traditional

COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE (K002691) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002691 · Com-Med International, Inc. · General Hospital
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Dec 2000
Decision
101d
Days
Class 2
Risk

K002691 is an FDA 510(k) clearance for the COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Com-Med International, Inc. (Grayslake, US). The FDA issued a Cleared decision on December 8, 2000 after a review of 101 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 Com-Med International, Inc. devices

Submission Details

510(k) Number K002691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2000
Decision Date December 08, 2000
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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 24
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K002691.
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997
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