Cleared Traditional

K122640 - VPULSE

K122640 is an FDA 510(k) clearance for VPULSE, manufactured by Cothera, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K122640 · Cothera, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
177d
Days
Class 2
Risk

K122640 is an FDA 510(k) clearance for the VPULSE. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Cothera, LLC (Washington, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Cothera, LLC devices

FDA 510(k) Submission Details - K122640

510(k) Number K122640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2012
Decision Date February 22, 2013
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 138
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K122640.
PCD 737A
K140642 · Mego Afek AC , Ltd. · Jun 2014
PETITE BASIC SYSTEM 701 ELT
K131420 · Mego Afek AC , Ltd. · Nov 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · Covidien · Aug 2013
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
K121962 · Mego Afek AC , Ltd. · Oct 2012
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K120944 · Covidien · May 2012
VENODYNE V810
K110358 · Microtek Medical, Inc. · May 2011