Bio Compression Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 15
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | December 12, 2025 |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | February 16, 2022 |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | May 14, 2021 |
| K180248 | VascuEase IC-1200-WH | August 7, 2018 |
| K171793 | Sequential Circulator SC-2004FC-OC | August 17, 2017 |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | July 16, 2015 |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL | November 6, 2014 |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | July 22, 2013 |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | July 18, 2013 |
| K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | April 9, 2013 |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | November 5, 2007 |
| K061857 | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR | August 1, 2006 |
| K043423 | MODEL SC-3008 SEQUENTIAL CIRCULATOR | February 1, 2005 |
| K961426 | BIO BOOST | October 28, 1996 |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | October 28, 1996 |