Circuflow 5208 Sequential Compression Device
FDA 510(k) K123647 · Devon Medical, Inc.
510(k) numberK123647
Submission
- Device name
- Circuflow 5208 Sequential Compression Device
- Applicant
- Devon Medical, Inc.
King Of Prussia, PA, US - Received
- November 27, 2012
- Decision date
- February 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| 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 |
More from Manamed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…OMP · Traditional | 09/19/2014SE |
| K141578 | Devon Cirona 6200 DVTJOW · Traditional | 06/27/2014SE |
| K132225 | ExtricareOMP · Traditional | 05/15/2014SE |
| K132252 | Extricare 100CC/ 250CC/ 400CC CanistersOMP · Special | 09/27/2013SE |
| K131464 | Extricare NPWT Foot DressingOMP · Special | 08/13/2013SE |
| K131743 | Cirona DVT Foot GarmentJOW · Traditional | 07/01/2013SE |
| K130571 | Devon Cirona 6100 DVTJOW · Traditional | 04/09/2013SE |
| K123959 | Circuflow 5150JOW · Traditional | 02/28/2013SE |
| K102582 | Arterioflow Model 7500 Sequential Compression DeviceJOW · Traditional | 10/07/2010SE |
| K101523 | Circuflow 5200 Sequential Compression DeviceJOW · Traditional | 06/17/2010SE |
Questions and answers
When was Circuflow 5208 Sequential Compression Device cleared by the FDA?
Circuflow 5208 Sequential Compression Device (K123647) received a 510(k) decision of Substantially Equivalent on February 14, 2013, 79 days after the submission was received.
What is the product code of K123647?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.