Huntleigh Flowpress AC300 Pump, SQ301/302/320 GAR

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K871271 ↗

FDA Product Code

DRM

Device Class

Class II

Regulation

21 CFR Part 870.5200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Huntleigh Dynamic Flotation System

  Class II

  FDA 510(k) K890012 Active Cleared 29 Mar 1989

• Huntleigh Double Bubble Air-O-Pad-AOP5

  Class II

  FDA 510(k) K882644 Active Cleared 10 Aug 1988

• Dopcord Ppg

  Class II

  FDA 510(k) K884451 Active Cleared 12 Jan 1989

• Multi Dopplex, Md-1

  Class II

  FDA 510(k) K900882 Active Cleared 22 Aug 1990

• Rheo Dopplex II (Rd 2)

  Class II

  FDA 510(k) K964699 Active Cleared 21 Feb 1997

• Akron ATP9 Traction Machine

  Class II

  FDA 510(k) K992733 Active Cleared 10 Nov 1999

See all devices from Huntleigh Technology, Inc. →

• What clinical conditions is the Huntleigh Flowpress AC300 Pump primarily used to manage, and how does it work?

  The Huntleigh Flowpress AC300 Pump is designed for sequential compression therapy, which helps manage circulatory disorders by promoting venous or lymphatic return. It achieves this through controlled pneumatic pressure cycles (30–100 mmHg) applied externally to limbs, reducing swelling and improving circulation. This is particularly useful for patients with conditions like deep vein thrombosis (DVT) prevention, chronic venous insufficiency, or post-surgical recovery where circulation support is beneficial.

• Is the Huntleigh Flowpress AC300 Pump intended for single-use or reusable applications, and what maintenance considerations should be noted?

  The Huntleigh Flowpress AC300 Pump is explicitly labeled as a reusable medical instrument, meaning it is engineered for repeated use in both clinical and home settings. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed per manufacturer guidelines to ensure safety, functionality, and longevity. The device requires standard electrical power (120V), so electrical safety standards should also be adhered to.

• What are the available models or variations of the Huntleigh Flowpress AC300 Pump, and how do they differ?

  The Huntleigh Flowpress AC300 Pump is available in three distinct models: SQ301, SQ302, and SQ302 GAR. While the exact functional differences between these models are not detailed in the specifications, the inclusion of ‘GAR’ in the SQ302 GAR variant may imply a specialized feature (e.g., additional controls or accessories). All models operate within the same pressure range (30–100 mmHg) and cycle time (~3 minutes), but the specific variations may cater to different clinical or user preferences.

• How is the Huntleigh Flowpress AC300 Pump regulated, and what does its FDA 510(k) clearance indicate?

  The Huntleigh Flowpress AC300 Pump holds FDA 510(k) clearance (K871271), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This classification places it under Class II regulatory oversight (DRM product code) and confirms it meets U.S. safety and performance standards for external cardiac compressors used in cardiovascular applications. The clearance was granted in 1987, and the device falls under the Cardiovascular (CV) advisory committee for review.