Cleared Traditional

K122405 - AIR-BAND RADIAL COMPRESSION DEVICE

K122405 is an FDA 510(k) clearance for AIR-BAND RADIAL COMPRESSION DEVICE, manufactured by Datascope Corp., Cardiac Assist Division. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K122405

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
Combination Product No
PCCP Authorized No
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.

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 140
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K122405.
SAM JUNCTIONAL TOURNIQUET
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K123194 · North American Rescue Products, Inc. · Jan 2013
SEAL ONE
K123035 · Perouse Medical · Nov 2012
K2 MEDICAL VASCULAR CLAMPS
K120492 · K2 Medical GmbH & Co. KG · Apr 2012
IM BAND
K113600 · Synexmed(Shenzhen)Company Limited · Feb 2012
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · Medtronic Xomed, Inc. · Jan 2012