Vaso Press System
FDA 510(k) K974393 · Britt Corp., Inc.
510(k) numberK974393
Submission
- Device name
- Vaso Press System
- Applicant
- Britt Corp., Inc.
Freehold, NJ, US - Received
- November 21, 1997
- Decision date
- March 19, 1999
- 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
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| 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 |
|---|---|---|
| K003828 | Vaso Press DVT Foot Garment #Vp 520JOW · Traditional | 05/18/2001SE |
| K991038 | Vaso Press DVT System, Models VP500, VP501JOW · Traditional | 06/22/2000SE |
| K860977 | Model 545-45 for Neurological Surgical ApplicationLLF · Traditional | 10/16/1986SE |
| K860975 | Model 545-45 Laser for Ear, Nose & ThroatEWG · Traditional | 07/18/1986SE |
| K860974 | Model 545-45 Laser for Derma., Pod., SurgicalGEX · Traditional | 07/07/1986SE |
| K860277 | Model 525-25 Watt C02 Laser for Ear, Nose & ThroatEWG · Traditional | 05/06/1986SE |
| K860273 | Model 525 - 25 Watt CO2 Medical Laser/PodiatryGEX · Traditional | 04/23/1986SE |
| K860278 | Model 525-25 Watt CO2 Laser for Derma/PlasticGEX · Traditional | 04/15/1986SE |
| K851425 | Model J25-25 Watt CO2 LaserHHR · Traditional | 11/12/1985SE |
| K840036 | Fitex · Traditional | 10/26/1984SE |
Questions and answers
When was Vaso Press System cleared by the FDA?
Vaso Press System (K974393) received a 510(k) decision of Substantially Equivalent on March 19, 1999, 483 days after the submission was received.
What is the product code of K974393?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.