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510(k) K231406

ClearumTM HS by Bellco Srl — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2023
Date Received
May 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 Bellco Srl

  • K193542 — Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 (October 8, 2020)
  • K160558 — RAPIDO HOLLOW-FIBRE DIALYZERS (November 18, 2016)

Other clearances for product code KDI

  • K260533 — ELISIO™-H (March 19, 2026)
  • 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)