Skip to content

Vaso Press System

by Britt Corp., Inc. 510(k)

Active United States

510(k) K974393

Overview

The Vaso Press System is a Sleeve, Limb, Compressible device designed to apply intermittent pneumatic compression for the treatment of venous and lymphatic disorders. It functions by inflating and deflating compressible sleeves around the limb to promote venous return and reduce the risk of deep vein thrombosis (DVT).

This system is supplied as a reusable medical device and is intended for use in clinical settings such as hospitals or outpatient care. It operates using a pneumatic pump mechanism and is paired with compatible sleeves (e.g., Model VP500 pump with VP501 sleeves). The device is classified as a Class 2 Cardiovascular device under FDA regulation 870.5800 and holds an FDA 510(k) clearance (K974393) through the Traditional pathway. Sizes and configurations are determined by the specific sleeve and pump combinations.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974393 Date19 Mar 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1346-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1343-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1348-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1344-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1347-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1345-2019 FDA Class II initiated 8 Apr 2019

    Product design change did not receive proper premarket clearance and lacks a 510 (k)

Specification

510(k)

510(k) Number
FDA Product Code
JOW
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Britt Corp., Inc.

See all devices from Britt Corp., Inc. →

Questions

  • What is the Vaso Press System used for?

    The Vaso Press System is designed to treat venous and lymphatic disorders by applying intermittent pneumatic compression. It works by inflating and deflating compressible sleeves around a limb, which promotes venous return and helps reduce the risk of deep vein thrombosis (DVT). This makes it particularly useful in clinical settings for patients at risk of circulation issues.

  • Is the Vaso Press System reusable or single-use?

    The Vaso Press System is a reusable medical device. It is intended for use in clinical settings such as hospitals or outpatient care, where durability and repeated use are essential for maintaining patient care standards.

  • How does the Vaso Press System operate?

    The device operates using a pneumatic pump mechanism paired with compatible sleeves, such as the VP501 sleeves for the VP500 pump. The pump inflates and deflates the sleeves around the limb, creating a rhythmic compression that aids blood flow and reduces swelling or clot formation.

  • What sizes or configurations are available for the Vaso Press System?

    The sizes and configurations of the Vaso Press System depend on the specific sleeve and pump combinations used. For example, the VP500 pump is designed to work with sleeves tailored to different limb sizes, ensuring a proper fit for effective compression therapy.

  • How should the Vaso Press System be stored?

    Since the Vaso Press System is reusable, it should be stored in a clean, dry environment when not in use. The pump and sleeves should be kept in their original packaging or a designated storage area to prevent contamination and ensure longevity. Follow manufacturer guidelines for maintenance and cleaning to preserve functionality.