Cleared Traditional

K140064 - SURGISLEEVE WOUND PROTECTOR

K140064 is the FDA 510(k) clearance for SURGISLEEVE WOUND PROTECTOR by Covidien. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K140064 · Covidien · General Hospital
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Mar 2014
Decision
61d
Days
Class 2
Risk

K140064 is an FDA 510(k) clearance for the SURGISLEEVE WOUND PROTECTOR. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on March 12, 2014 after a review of 61 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 Covidien devices

Submission Details

510(k) Number K140064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2014
Decision Date March 12, 2014
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K140064.
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K083234 · Kimberly-Clark Corp. · Mar 2009
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007