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B.braun 7102230

by B.Braun Avitum AG

B.braun 7102230 is a haemodialysis system (FDA Class II; FDA product code KDI, Dialyzer, high permeability with or without sealed dialysate system) made by B.Braun Avitum AG, cleared under FDA 510(k) K083460 on 18 Feb 2010 (1 earlier submission) and listed in FDA GUDID since 9 Aug 2015 (UDI-DI 04046963686734), active as of 22 Oct 2026. 8 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04046963686734 UDI-DI Date9 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083460 Date18 Feb 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083460 decided 18 Feb 2010 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04046963686734 listed 9 Aug 2015 Listed

Recalls

8 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0872-2022 FDA Class II initiated 28 Jan 2022
    • Terminated Z-0873-2022 FDA Class II initiated 28 Jan 2022

    Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

  • 6 recalls, same reason

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

    Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Timeline

11 dated events

  1. Cleared FDA 510(k) K083460
  2. Listed FDA GUDID 04046963686734
  3. Recall initiated FDA recalls Z-1532-2016
  4. Recall initiated FDA recalls Z-1535-2016
  5. Recall initiated FDA recalls Z-1531-2016
  6. Recall initiated FDA recalls Z-1536-2016
  7. Recall initiated FDA recalls Z-1533-2016
  8. Recall initiated FDA recalls Z-1534-2016
  9. Recall initiated FDA recalls Z-0872-2022
  10. Recall initiated FDA recalls Z-0873-2022

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
B.braun
Generic name
Haemodialysis system, institutional
Model / Ref / Catalog
7102230
Primary DI / UDI-DI
04046963686734
510(k) Number
FDA product code
KDI
GMDN term
Haemodialysis system, institutional
Device class
Class II
Regulation number
876.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemodialysis system, institutional

Cleared under the same submission (K083460)

and 8 more cleared under K083460

Cleared under the same submission (K963440)

and 8 more cleared under K963440

Similar devices

Other devices filed under FDA product code KDI (Dialyzer, high permeability with or without sealed dialysate system).

Other devices from B.Braun Avitum AG

See all devices from B.Braun Avitum AG →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)