Medical Device Manufacturer · US , Moonachie , NJ

Bio Compression Systems, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1996
15
Total
15
Cleared
0
Denied

Bio Compression Systems, Inc. has 15 FDA 510(k) cleared cardiovascular devices. Based in Moonachie, US.

Latest FDA clearance: Dec 2025. Active since 1996.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Bio Compression Systems, Inc.
15 devices
1-15 of 15
Cleared Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · JOW
Cardiovascular · 256d
Cleared Feb 16, 2022
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K213533 · IRP
Physical Medicine · 103d
Cleared May 14, 2021
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K210417 · JOW
Cardiovascular · 92d
Cleared Aug 07, 2018
VascuEase IC-1200-WH
K180248 · JOW
Cardiovascular · 190d
Cleared Aug 17, 2017
Sequential Circulator SC-2004FC-OC
K171793 · JOW
Cardiovascular · 62d
Cleared Jul 16, 2015
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
K150953 · JOW
Cardiovascular · 98d
Cleared Nov 06, 2014
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial...
K142640 · JOW
Cardiovascular · 50d
Cleared Jul 22, 2013
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K131306 · JOW
Cardiovascular · 76d
Cleared Jul 18, 2013
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K131327 · JOW
Cardiovascular · 71d
Cleared Apr 09, 2013
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
K122112 · IRP
Physical Medicine · 266d
Cleared Nov 05, 2007
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K072666 · JOW
Cardiovascular · 45d
Cleared Aug 01, 2006
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
K061857 · JOW
Cardiovascular · 32d
Cleared Feb 01, 2005
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · JOW
Cardiovascular · 50d
Cleared Oct 28, 1996
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER...
K961425 · ILO
Physical Medicine · 199d
Cleared Oct 28, 1996
BIO BOOST
K961426 · IRP
Physical Medicine · 199d
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