Cleared Special

Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC (K150953) - FDA 510(k) Clearance

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

K150953 · Bio Compression Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
98d
Days
Class 2
Risk

K150953 is an FDA 510(k) clearance for the Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on July 16, 2015 after a review of 98 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 Bio Compression Systems, Inc. devices

Submission Details

510(k) Number K150953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2015
Decision Date July 16, 2015
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 92
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K150953.
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
K163620 · Covidien · Jan 2017
Reprocessed Kendall SCD Express Foot Cuff
K163055 · Covidien · Dec 2016
Reprocessed Compression Garments
K161105 · Covidien · Aug 2016
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · Covidien · Jul 2014
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · Covidien · Aug 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K120944 · Covidien · May 2012