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Aquadex FlexFlow System

by Chf Solutions, Inc. 2 variants

510(k) K060008

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060008 Date2 Feb 2006ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KDI
Device Class
Class II
Regulation
21 CFR Part 876.5860
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aquadex FlexFlow System is a high-permeability dialyzer with or without a sealed dialysate system, classified as a Class II medical device. It is designed to perform ultrafiltration, a process used to remove excess fluid and solutes from a patient’s bloodstream, particularly in cases of fluid overload where diuretic therapy has failed. The system facilitates both short-term (up to 8 hours) and extended ultrafiltration treatments, supporting renal support therapies in clinical settings.

The device is supplied as a reusable component within a regulated medical system and is intended for use in hemodialysis or hemofiltration procedures. It operates in controlled environments such as dialysis centers or intensive care units, adhering to sterile processing protocols. The system’s design includes multiple reference codes (e.g., KDI, K060008) and is authorized under FDA 510(k) clearance as substantially equivalent to prior devices. No MRI safety or single-use specifications are indicated in the data.

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