Cleared Traditional

K042137 - PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

K042137 is an FDA 510(k) clearance for PROMEDICAL SURGICAL MAYO STAND COVERS, manufactured by Promedical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K042137 · Promedical Products Co., Ltd. · General Hospital
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Oct 2004
Decision
57d
Days
Class 2
Risk

K042137 is an FDA 510(k) clearance for the PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT .... Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Promedical Products Co., Ltd. (Starkville, US). The FDA issued a Cleared decision on October 5, 2004 after a review of 57 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 Promedical Products Co., Ltd. devices

FDA 510(k) Submission Details - K042137

510(k) Number K042137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date October 05, 2004
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
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 229
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K042137.
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005
MICROTEK EQUIPMENT DRAPES
K050322 · Microtek Medical, Inc. · May 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
ALEXIS WOUND RETRACTOR
K031889 · Applied Medical Resources Corp. · Sep 2003
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
DEROYAL DRAPES, STERILE, NON-STERILE
K030365 · Deroyal Industries, Inc. · Apr 2003