FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K Number: K210417
·
Decision May 14, 2021
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
15
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K Number
- K210417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio Compression Systems, Inc.
- Date Received
- February 11, 2021
- Decision Date
- May 14, 2021
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOW), ordered by most recent decision date.
Compression Therapy Device (LGT-2202DVT)
FDA 510(k)
FDA Class 2
·Cardiovascular
NanoPress 760A-BT (760A-BT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Bio Arterial Deluxe (IC-BAP-DX)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sequential Compression System (SCD600)
FDA 510(k)
FDA Class 2
·Cardiovascular
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
FDA 510(k)
FDA Class 2
·Cardiovascular
PlasmaFlow X Compression Sleeve Device (XPF0001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Bio Compression Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Dec 12, 2025 | Substantially Equivalent |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Feb 16, 2022 | Substantially Equivalent |
| K180248 | VascuEase IC-1200-WH | Aug 7, 2018 | Substantially Equivalent |
| K171793 | Sequential Circulator SC-2004FC-OC | Aug 17, 2017 | Substantially Equivalent |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | Jul 16, 2015 | 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 | Nov 6, 2014 | Substantially Equivalent |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | Jul 22, 2013 | Substantially Equivalent |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Jul 18, 2013 | Substantially Equivalent |
| K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | Apr 9, 2013 | Substantially Equivalent |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Nov 5, 2007 | Substantially Equivalent |