Bio Compression Systems, Inc.
Moonachie, NJ, US
BIO COMPRESSION SYSTEMS, INC. appears in FDA device records in Moonachie, NJ. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Bio Compression Systems, Inc. between 1996 and 2025. The busiest year on record is 2013, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | JOW | Substantially Equivalent | |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | IRP | Substantially Equivalent | |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | JOW | Substantially Equivalent | |
| K180248 | VascuEase IC-1200-WH | JOW | Substantially Equivalent | |
| K171793 | Sequential Circulator SC-2004FC-OC | JOW | Substantially Equivalent | |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | JOW | Substantially Equivalent | |
| 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 | |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | JOW | Substantially Equivalent | |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | JOW | Substantially Equivalent | |
| K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | IRP | Substantially Equivalent | |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | JOW | Substantially Equivalent | |
| K061857 | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR | JOW | Substantially Equivalent | |
| K043423 | MODEL SC-3008 SEQUENTIAL CIRCULATOR | JOW | Substantially Equivalent | |
| K961426 | BIO BOOST | IRP | Substantially Equivalent | |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS | ILO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2424387 | 2424387 | BIO COMPRESSION SYSTEMS, INC. | 120 WEST COMMERCIAL AVE., MOONACHIE, NJ 07074 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain