Cleared Traditional

K140250 - 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE

K140250 is an FDA 510(k) clearance for 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE..., manufactured by 3M Healthcare. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K140250 · 3M Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
175d
Days
Class 2
Risk

K140250 is an FDA 510(k) clearance for the 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on July 25, 2014 after a review of 175 days - an extended review 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: 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 3M Healthcare devices

FDA 510(k) Submission Details - K140250

510(k) Number K140250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2014
Decision Date July 25, 2014
Days to Decision 175 days
Submission Type Traditional
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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 263
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K140250.
SURGICAL DRAPE
K140195 · Griffith-Lucas, LLC · Sep 2014
3M STERI-DRAPE FABRIC SURGICAL DRAPES
K140330 · 3M Healthcare · Aug 2014
WHITNEY MEDICAL SOLUTIONS ESHIELD
K141438 · Whitney Medical Solutions · Aug 2014
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
AVD RIGHT RADIAL DRAPE
K131571 · Advanced Vascular Dynamics · Jan 2014
TIBURON SURGICAL DRAPE
K130404 · Cardinal Health200, LLC · Jul 2013