Cleared Special

K122873 - VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K122873 · Caremed Supply, Inc. · Cardiovascular device
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Jan 2013
Decision
118d
Days
Class 2
Risk

K122873 is an FDA 510(k) clearance for the VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Caremed Supply, Inc. (Taipei Xen District, CN). The FDA issued a Cleared decision on January 15, 2013 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Caremed Supply, Inc. devices

Submission Details

510(k) Number K122873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2012
Decision Date January 15, 2013
Days to Decision 118 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 349
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