Cleared Traditional

K905005 - DISPOSABLE SURGICAL TOWEL (NON-STERILE)

K905005 is an FDA 510(k) clearance for DISPOSABLE SURGICAL TOWEL (NON-STERILE), manufactured by Marand Products, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K905005 · Marand Products, Inc. · General Hospital
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Dec 1990
Decision
34d
Days
Class 2
Risk

K905005 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL TOWEL (NON-STERILE). Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Marand Products, Inc. (Deer Park, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marand Products, Inc. devices

FDA 510(k) Submission Details - K905005

510(k) Number K905005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date December 11, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
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 290
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K905005.
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694 · Customed, Inc. · Jan 1991
ORION STERILE OR TOWELS
K903117 · Orion Life Systems, Inc. · Dec 1990
QUALTEX SURGICAL DRAPE
K904960 · Deroyal Industries, Inc. · Dec 1990
CUSTOMED CYSTO PACK II
K901705 · Customed, Inc. · Oct 1990
CUSTOMED LAP PACK II
K902191 · Customed, Inc. · Oct 1990
CUSTOMED BASIC PACK I
K902884 · Customed, Inc. · Sep 1990