Cleared Traditional

K100991 - IMC SURGICAL DRAPE

K100991 is an FDA 510(k) clearance for IMC SURGICAL DRAPE, 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 179-day FDA review.

K100991 · International Medsurg Connection · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
179d
Days
Class 2
Risk

K100991 is an FDA 510(k) clearance for the IMC SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by International Medsurg Connection (Schaumburg, US). The FDA issued a Cleared decision on October 5, 2010 after a review of 179 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 International Medsurg Connection devices

FDA 510(k) Submission Details - K100991

510(k) Number K100991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2010
Decision Date October 05, 2010
Days to Decision 179 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
50d slower than avg
Panel avg: 129d · This submission: 179d
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 166
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K083234 · Kimberly-Clark Corp. · Mar 2009