Cleared Traditional

K111837 - RADIAL ARTERY COMPRESSION TOURNIQUET

K111837 is an FDA 510(k) clearance for RADIAL ARTERY COMPRESSION TOURNIQUET, manufactured by Lepu Medical Technology (Beijing) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K111837 · Lepu Medical Technology (Beijing) Co., Ltd. · Cardiovascular device
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Sep 2011
Decision
90d
Days
Class 2
Risk

K111837 is an FDA 510(k) clearance for the RADIAL ARTERY COMPRESSION TOURNIQUET. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Lepu Medical Technology (Beijing) Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on September 27, 2011 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Lepu Medical Technology (Beijing) Co., Ltd. devices

FDA 510(k) Submission Details - K111837

510(k) Number K111837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2011
Decision Date September 27, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 189
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K111837.
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC · Dec 2011
ABDOMINAL TOURNIQUET SYSTEM
K112384 · Compression Works, LLC · Oct 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · Edwards Lifesciences, LLC · Oct 2011
WEXLER VASCULAR CLAMP SERIES
K110148 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · Apr 2011
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH
K110193 · St. Jude Medical Systems AB · Feb 2011
ATRAUMATIC VASCULAR CLAMPS
K102048 · Geomed Medizin-Technik GmbH & Co. KG · Nov 2010