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510(k) K232467

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine by Baxter Healthcare Corporation — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
August 15, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Baxter Healthcare Corporation

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  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K243529 — Solution Administration Sets (March 14, 2025)
  • K242339 — Intravascular Extension Sets and Accessories (February 28, 2025)
  • K242390 — Novum IQ Syringe Pump (40800BAXUS) (September 5, 2024)
  • K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE M (August 2, 2024)
  • K211122 — Novum IQ Large Volume Pump (March 29, 2024)
  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K230041 — Spectrum IQ Infusion System with Dose IQ Safety Software (March 31, 2023)

Other clearances for product code KDI

  • K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (February 10, 2026)
  • K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U) (January 26, 2026)
  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)
  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)