Aircast Venaflow System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K932900 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Venaflow System, Model 30A

  Class II

  FDA 510(k) K992454 Active Cleared 13 Jan 2000

• Arterialflow System, Model 32A

  Class II

  FDA 510(k) K024019 Active Cleared 3 Jun 2003

• Autochill Accessory Kit

  Class II

  FDA 510(k) K925677 Active Cleared 14 Apr 1993

• Aircast Venaflow System (Modification)

  Class II

  FDA 510(k) K961676 Active Cleared 28 Mar 1997

• Airstirrup Pneumatic Ankle Brace

  Class I

  FDA 510(k) K780979 Active Cleared 30 Jun 1978

• Aircast Pneumatic Knee Brace

  Class I

  FDA 510(k) K812094 Active Cleared 13 Aug 1981

See all devices from Aircast, Inc. →

• What is the Aircast Venaflow System used for?

  The Aircast Venaflow System is designed for prophylaxis of Deep Vein Thrombosis (DVT) in patients with limited mobility or post-surgical recovery needs. It utilizes pneumatic compression technology to help prevent blood clots.

• How is the Aircast Venaflow System supplied?

  The device is supplied for use in clinical settings or at home. It is intended for single-patient use to maintain sterility and prevent cross-contamination, with multiple registration numbers for regulatory compliance.

• What is the regulatory status of the Aircast Venaflow System?

  The Aircast Venaflow System is regulated under FDA 510K clearance with product code JOW. It is classified as a Class II medical device and has received FDA clearance as substantially equivalent to predicate devices.

• Can the Aircast Venaflow System be reused?

  No, the Aircast Venaflow System is intended for single-patient use only. This design maintains sterility and prevents cross-contamination between patients, ensuring safety and effectiveness.