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Drake Willock System & Altra Touch 1000 Dialysis Delivery System

by Althin Medical AB an Affiliate of Baxter Intl

510(k) K970446

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK970446 Date2 Jun 1997ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0173-2012 FDA Unclassified (pre-2012) initiated 19 Sep 2011

    The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.

    • Terminated Z-1253-06 FDA Unclassified (pre-2012) initiated 21 Jun 2006

    The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.

    • Terminated Z-1394-05 FDA Unclassified (pre-2012) initiated 14 Jun 2005 on shared 510(k) K970446

    Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.

    • Terminated Z-0367-05 FDA Unclassified (pre-2012) initiated 14 Dec 2004 on shared 510(k) K970446

    Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.

    • Terminated Z-0583-04 FDA Unclassified (pre-2012) initiated 20 Feb 2004 on shared 510(k) K970446

    These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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