Sequential Circulator (SC-4004-DL, SC-4008-DL)
FDA 510(k) K261807 · Bio Compression Systems, Inc.
510(k) numberK261807
Submission
- Device name
- Sequential Circulator (SC-4004-DL, SC-4008-DL)
- Applicant
- Bio Compression Systems, Inc.
Moonachie, NJ, US - Received
- June 1, 2026
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code JOW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
| K250242 | Compression Therapy Device (LGT-2202DVT)JOW · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 04/24/2026SE |
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | Shenzhen Comen Medical Instruments Co.,Ltd | 12/08/2025SE |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
| K251086 | PnueAira (PNCU-01)JOW · Traditional | Biotab, LLC | 08/18/2025SE |
More from Biotab, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | 12/12/2025SE |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…IRP · Traditional | 02/16/2022SE |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL…JOW · Traditional | 05/14/2021SE |
| K180248 | VascuEase IC-1200-WHJOW · Traditional | 08/07/2018SE |
| K171793 | Sequential Circulator SC-2004FC-OCJOW · Special | 08/17/2017SE |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OCJOW · Special | 07/16/2015SE |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model…JOW · Traditional | 11/06/2014SE |
| K131306 | IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression DeviceJOW · Traditional | 07/22/2013SE |
| K131327 | Bioarterial Plus Arterial Blood Flow Enhancement SystemJOW · Traditional | 07/18/2013SE |
| K122112 | 2004-OC Massage System, 2008-OC Massage SystemIRP · Traditional | 04/09/2013SE |
Questions and answers
When was Sequential Circulator (SC-4004-DL, SC-4008-DL) cleared by the FDA?
Sequential Circulator (SC-4004-DL, SC-4008-DL) (K261807) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 102 days after the submission was received.
What is the product code of K261807?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.