Cleared Traditional

K122000 - HM SURGICAL DRAPES HM SURGICAL EQUIPMEN...

K122000 is an FDA 510(k) clearance for HM SURGICAL DRAPES HM SURGICAL EQUIPMEN..., manufactured by Changzhou Holymed Products Co., Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K122000 · Changzhou Holymed Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
156d
Days
Class 2
Risk

K122000 is an FDA 510(k) clearance for the HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Changzhou Holymed Products Co., Ltd. (Changhou, CN). The FDA issued a Cleared decision on December 12, 2012 after a review of 156 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 Changzhou Holymed Products Co., Ltd. devices

FDA 510(k) Submission Details - K122000

510(k) Number K122000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2012
Decision Date December 12, 2012
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
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 179
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K122000.
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
TIBURON SURGICAL DRAPE
K130404 · Cardinal Health200, LLC · Jul 2013
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010
BUSSE SURGICAL DRAPES IV
K093909 · Busse Hospital Disposables, Inc. · May 2010
BUSSE SURGICAL DRAPES III
K092212 · Busse Hospital Disposables, Inc. · Oct 2009