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510(k) K112314

NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER by Nephros, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
August 11, 2011
Clearance Type
Traditional
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 Nephros, Inc.

  • K210575 — HDF Assist Mudule, HDF Infusion Set and Substitution Filter (May 13, 2022)
  • K161304 — EndoPur Filter (March 2, 2017)
  • K161467 — HydraGuard 10 UltraFilter (December 22, 2016)
  • K153084 — Nephros S100 (April 8, 2016)
  • K141731 — NEPHROS DSU-H, NEPHROS SSU-H (October 24, 2014)
  • K110285 — NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (July 14, 2011)
  • K090885 — NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER (June 29, 2009)
  • K050603 — OLPUR DIALYZER, MODEL HD 190 (June 9, 2005)

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)