Bio Compression Systems, Inc. is one of 16060 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bio Compression Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sequential Circulator (SC-4004-DL, SC-4008-DL), Bio Arterial Deluxe (IC-BAP-DX), Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
16
Total
16
Cleared
0
Denied
Bio Compression Systems, Inc. has 16 FDA 510(k) cleared cardiovascular devices. Based in Moonachie, US.
Latest FDA clearance: Sep 2026. 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.
Regulatory submissions have been managed by Intertek Testing Services and Entela, Inc..
FDA 510(k) Regulatory Record - Bio Compression Systems, Inc.
16 devices
Cleared
Sep 11, 2026
Sequential Circulator (SC-4004-DL, SC-4008-DL)
Cardiovascular
102d
Cleared
Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
Cardiovascular
256d
Cleared
Feb 16, 2022
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
Physical Medicine
103d
Cleared
May 14, 2021
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
Cardiovascular
92d
Cleared
Aug 07, 2018
VascuEase IC-1200-WH
Cardiovascular
190d
Cleared
Aug 17, 2017
Sequential Circulator SC-2004FC-OC
Cardiovascular
62d
Cleared
Jul 16, 2015
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
Cardiovascular
98d
Cleared
Nov 06, 2014
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial...
Cardiovascular
50d
Cleared
Jul 22, 2013
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
Cardiovascular
76d
Cleared
Jul 18, 2013
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
Cardiovascular
71d
Cleared
Apr 09, 2013
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
Physical Medicine
266d
Cleared
Nov 05, 2007
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
Cardiovascular
45d