Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017
FDA 510(k) K023800 · Aircast, Inc.
510(k) numberK023800
Submission
- Device name
- Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017
- Applicant
- Aircast, Inc.
Summit, NJ, US - Received
- November 14, 2002
- Decision date
- February 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
|---|---|---|
| K024019 | Arterialflow System, Model 32AJOW · Traditional | 06/03/2003SE |
| K992454 | Venaflow System, Model 30AJOW · Traditional | 01/13/2000SE |
| K964238 | Aircast Vena Flow Sterile Disposable CuffsJOW · Traditional | 09/08/1997SE |
| K961676 | Aircast Venaflow System (Modification)JOW · Traditional | 03/28/1997SE |
| K933977 | Aircast Edemaflow SystemJOW · Traditional | 12/07/1993SE |
| K932900 | Aircast Venaflow SystemJOW · Traditional | 10/25/1993SE |
| K925677 | Autochill Accessory KitILO · Traditional | 04/14/1993SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | 08/13/1981SE |
| K810288 | Aircast Tennis Arm BandIQI · Traditional | 02/12/1981SE |
| K780979 | Airstirrup Pneumatic Ankle BraceIQI · Traditional | 06/30/1978SE |
Questions and answers
When was Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017 cleared by the FDA?
Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017 (K023800) received a 510(k) decision of Substantially Equivalent on February 10, 2003, 88 days after the submission was received.
What is the product code of K023800?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.