Skip to content

Dialog Dialysis Machine

by B. Braun Medical AG

510(k) K963440

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK963440 Date26 Jun 1998ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1531-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1534-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1532-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1535-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1533-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1536-2016 FDA Class I initiated 1 Apr 2016

    Potential leakage of conductivity sensors of the Dialog Dialysis machines.

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  • Withdrawn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

Other devices from B. Braun Medical AG

See all devices from B. Braun Medical AG →