Cleared Traditional

K140330 - 3M STERI-DRAPE FABRIC SURGICAL DRAPES

K140330 is the FDA 510(k) clearance for 3M STERI-DRAPE FABRIC SURGICAL DRAPES by 3M Healthcare. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K140330 · 3M Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
189d
Days
Class 2
Risk

K140330 is an FDA 510(k) clearance for the 3M STERI-DRAPE FABRIC SURGICAL DRAPES. 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 August 18, 2014 after a review of 189 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

Submission Details

510(k) Number K140330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date August 18, 2014
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
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 146
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K140330.
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · 3M Company · May 2023
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009