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Hospal Multiflow 100, Multiflow 100 Kits A0 (A0, A0/B and A0/0), Multiflow 100 Kits B22 (B22, B22/B, & B22/0)

by Gambro Healthcare

510(k) K980386

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK980386 Date24 Feb 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0705-06 FDA Unclassified (pre-2012) initiated 24 Oct 2005

    After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

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  • Withdrawn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, 27 Sep 2026

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

The device is a dialyzer with high permeability, with or without a sealed dialysate system, as defined in the device data. It is classified as a Class 2 medical device under FDA regulations.

The device received FDA 510(k) clearance (K980386) through the traditional pathway on February 24, 1999, after a 387-day review. It is manufactured by Gambro Healthcare and is indicated for use in gastroenterology and urology settings, as reflected in the advisory committee assignment. The device is supplied as a kit system including the specified models and configurations.

Other devices from Gambro Healthcare

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the HOSPAL MULTIFLOW 100 used for?

    The HOSPAL MULTIFLOW 100 is a dialyzer indicated for use in gastroenterology and urology settings, as reflected in its advisory committee assignment, and is designed for high permeability dialysis with or without a sealed dialysate system.

  • How is the HOSPAL MULTIFLOW 100 supplied and what configurations are available?

    The device is supplied as a kit system including the MULTIFLOW 100 KITS A0 (A0, A0/B and A0/0) and MULTIFLOW 100 KITS B22 (B22, B22/B, and B22/0) configurations, as specified in the device name and manufacturer data.

  • Is the HOSPAL MULTIFLOW 100 a single-use or reusable device?

    As a dialyzer kit system intended for dialysis treatment, the HOSPAL MULTIFLOW 100 is designed for single-use only, consistent with standard dialysis device safety and infection control practices, though reuse protocols would depend on clinical facility policies not specified in the device data.