Cleared Traditional

K031287 - STERI-DRAPE SURGICAL DRAPES

K031287 is the FDA 510(k) clearance for STERI-DRAPE SURGICAL DRAPES by 3M Company. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K031287 · 3M Company · General Hospital
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Sep 2003
Decision
140d
Days
Class 2
Risk

K031287 is an FDA 510(k) clearance for the STERI-DRAPE SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on September 10, 2003 after a review of 140 days - within the typical 510(k) review window.

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 Company devices

Submission Details

510(k) Number K031287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date September 10, 2003
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 134
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K031287.
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
ALEXIS WOUND RETRACTOR
K031889 · Applied Medical Resources Corp. · Sep 2003
DEROYAL DRAPES, STERILE, NON-STERILE
K030365 · Deroyal Industries, Inc. · Apr 2003
TRILAMINATE DRAPES/TIBURON
K023419 · Allegiance Healthcare Corp. · Feb 2003
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · Allegiance Healthcare Corp. · Nov 2002