Cleared Traditional

K971159 - SURGICAL DRAPES

K971159 is an FDA 510(k) clearance for SURGICAL DRAPES, manufactured by International Medsurg Connection. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K971159 · International Medsurg Connection · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
85d
Days
Class 2
Risk

K971159 is an FDA 510(k) clearance for the SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by International Medsurg Connection (Schaumberg, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 85 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 International Medsurg Connection devices

FDA 510(k) Submission Details - K971159

510(k) Number K971159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1997
Decision Date June 24, 1997
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 283
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K971159.
OPPORTUNITY, INC. LACERATION TRAY
K971089 · Opportunity, Inc. · Sep 1997
BOUFFANT CAP
K972187 · American Seal Co. · Sep 1997
DRAPE, SURGICAL-LATEX
K970891 · Protek Medical Products, Inc. · Aug 1997
CONVERTORS SMS DRAPES
K970554 · Allegiance Healthcare Corp. · May 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185 · Contour Fabricators, Inc. · Apr 1997
EYE TRAY
K970722 · Trinity Laboratories, Inc. · Mar 1997