Cleared Traditional

K002691 - COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE

K002691 is an FDA 510(k) clearance for COM-MED O.R. TOWEL - NON-STERILE, manufactured by Com-Med International, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K002691

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.

KKX Device Classification - Class 2, Special Controls

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 260
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K002691.
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · Advance Medical Designs, Inc. · Sep 2001
SURGICAL DRAPES
K011422 · Advance Medical Designs, Inc. · Jul 2001
PATIENT DRAPE, SURGICAL
K003670 · Advance Medical Designs, Inc. · Jan 2001
NEUROTOLOGY DRAPE, MODEL TBD
K002702 · Gyrus Ent LLC · Oct 2000
EQUIPMENT DRAPES
K002508 · Allegiance Healthcare Corp. · Sep 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp. · Jun 2000