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Extracorporeal Blood Pumping Syst for Hemofiltrat

by Baxter Healthcare Corp

510(k) K911315

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 NumberK911315 Date30 Oct 1991ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0681-06 FDA Unclassified (pre-2012) initiated 21 Dec 2005

    Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.

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  • Withdrawn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
KOC
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

An extracorporeal blood pumping system for hemofiltration is a device used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions. It functions by pumping blood through tubing external to the body, forming a critical component of hemodialysis therapy.

This system is supplied as an accessory to hemodialysis equipment and is intended for use in clinical settings such as hospitals or dialysis centers. It is a reusable device, not sterile, and has received FDA 510(k) clearance (K911315) under product code KOC, classified as a Class II device with special controls.

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Questions

AI-generated answers, 25 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 extracorporeal blood pumping system for hemofiltration used for?

    It is used as part of an artificial kidney system to pump blood through tubing external to the body, forming a critical component of hemodialysis therapy for patients with renal failure or toxemic conditions.

  • Is the extracorporeal blood pumping system sterile or single-use?

    The device is supplied as a non-sterile, reusable accessory intended for multiple uses in clinical settings such as hospitals and dialysis centers, and is not designed for single-use disposal.

  • How is the extracorporeal blood pumping system supplied and where is it used?

    It is supplied as an accessory to hemodialysis equipment and is intended for use in clinical environments including hospitals and dialysis centers, where it integrates into hemodialysis therapy setups.

  • What regulatory clearance does the extracorporeal blood pumping system have?

    The device has received FDA 510(k) clearance under submission number K911315, classified as a Class II device with product code KOC, and was determined to be substantially equivalent to a predicate device.