Cleared Special

K012807 - MODIFICATION TO: COMPEL SURGICAL DRAPES

K012807 is an FDA 510(k) clearance for MODIFICATION TO: COMPEL SURGICAL DRAPES, manufactured by Standard Textile Co., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Special 510(k) pathway after a 50-day FDA review.

K012807 · Standard Textile Co., Inc. · General Hospital
Download Printable Device Report (PDF)
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Oct 2001
Decision
50d
Days
Class 2
Risk

K012807 is an FDA 510(k) clearance for the MODIFICATION TO: COMPEL SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 11, 2001 after a review of 50 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K012807

510(k) Number K012807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2001
Decision Date October 11, 2001
Days to Decision 50 days
Submission Type Special
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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 202
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K012807.
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
WOUND PROTECTOR/RETRACTOR
K020435 · Applied Medical Resources Corp. · Apr 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957 · Dynarex Corp. · Mar 2002
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