Cleared Traditional

K122405 - AIR-BAND RADIAL COMPRESSION DEVICE

K122405 is the FDA 510(k) clearance for AIR-BAND RADIAL COMPRESSION DEVICE by Datascope Corp., Cardiac Assist Division. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K122405 · Datascope Corp., Cardiac Assist Division · Cardiovascular device
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Nov 2012
Decision
94d
Days
Class 2
Risk

K122405 is an FDA 510(k) clearance for the AIR-BAND RADIAL COMPRESSION DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Datascope Corp., Cardiac Assist Division (Fairfield, US). The FDA issued a Cleared decision on November 9, 2012 after a review of 94 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 Datascope Corp., Cardiac Assist Division devices

Submission Details

510(k) Number K122405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2012
Decision Date November 09, 2012
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K122405.
TRAcelet Compression Device
K162027 · Medtronic Vascular · Oct 2016
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K132175 · Edwards Lifesciences, LLC · Sep 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · Boston Scientific Corporation · Jun 2013
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC · Dec 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · Edwards Lifesciences, LLC · Oct 2011
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007