Data / Medical devices / United States / Bio Compression Systems, Inc.
Bio Compression Systems, Inc.: FDA-registered device maker in Moonachie, NJ, United States, 15 510(k) clearances
Bio Compression Systems, Inc. is registered with the FDA (registration 2424387) in Moonachie, NJ, United States. It lists 3 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2424387
- Address
- 120 West Commercial Ave., Moonachie, NJ, United States, 07074
- Owner or operator
- Bio Compression Systems, Inc (2424387)
- Roles
- Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2026
- Brand names listed
- 2004-OC Massage System, 2008-OC Massage System, A8-3045-L 8-Chamber Adjustable Leg Sleeve - Large, A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable, A8-3045-M 8-Chamber Adjustable Leg Sleeve - Medium, A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable, A8-3045-S 8-Chamber Adjustable Leg Sleeve - Small, A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable, APG-3035-FA Arterial Arm Sleeve and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| December 12, 2025 | K250974 | Bio Arterial Deluxe (IC-BAP-DX) | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| February 16, 2022 | K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | IRP | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| May 14, 2021 | K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| August 7, 2018 | K180248 | VascuEase IC-1200-WH | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| August 17, 2017 | K171793 | Sequential Circulator SC-2004FC-OC | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| July 16, 2015 | K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| November 6, 2014 | K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| July 22, 2013 | K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| July 18, 2013 | K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| April 9, 2013 | K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | IRP | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| November 5, 2007 | K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061857 | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| February 1, 2005 | K043423 | MODEL SC-3008 SEQUENTIAL CIRCULATOR | JOW | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
| October 28, 1996 | K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | ILO | Substantially Equivalent | Bio Compression Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Massager, Powered Inflatable Tube
- All makers of Pack, Hot Or Cold, Water Circulating
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.