Cleared Traditional

IMC DRAPES (K050538) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050538 · Intl. Medsurg Connection, Inc. · General Hospital
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Jun 2005
Decision
97d
Days
Class 2
Risk

K050538 is an FDA 510(k) clearance for the IMC DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Intl. Medsurg Connection, Inc. (Schaumburg, US). The FDA issued a Cleared decision on June 7, 2005 after a review of 97 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 Intl. Medsurg Connection, Inc. devices

Submission Details

510(k) Number K050538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date June 07, 2005
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 23
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K050538.
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002