Cleared Traditional

K101350 - RADSCAN EQUIPMENT SLICKER

K101350 is an FDA 510(k) clearance for RADSCAN EQUIPMENT SLICKER, manufactured by Radscan Medical Equipment, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K101350 · Radscan Medical Equipment, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
235d
Days
Class 2
Risk

K101350 is an FDA 510(k) clearance for the RADSCAN EQUIPMENT SLICKER. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Radscan Medical Equipment, Inc. (Phoenix, US). The FDA issued a Cleared decision on January 4, 2011 after a review of 235 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.

FDA 510(k) Submission Details - K101350

510(k) Number K101350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2010
Decision Date January 04, 2011
Days to Decision 235 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 129d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 373
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K101350.
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
K111458 · Gri Medical & Electronic Technology Co., Ltd. · Dec 2011
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
K112136 · Kunshan Jiehong Nonwoven Product Co., Ltd. · Sep 2011
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
K102861 · A Plus International, Inc. · Jan 2011
NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H
K094016 · Hinson and Hale Medical Technologies, Inc. · Nov 2010
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010
IMC SURGICAL DRAPE
K100991 · International Medsurg Connection · Oct 2010
K101350 · RADSCAN EQUIPMENT SLICKER
Download PDF FDA Summary Radscan Medical Equip…