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510(k) K182940

Surdial DX Hemodialysis System by Nipro Medical Corporation — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2019
Date Received
October 23, 2018
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 Nipro Medical Corporation

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  • K212677 — aboNT SYRINGE (April 15, 2022)
  • K190037 — Cronus HP PTA Balloon Catheter (October 24, 2019)
  • K191359 — Nipro Syringe (October 9, 2019)
  • K173029 — Nipro Syringe (March 30, 2018)
  • K161681 — Nipro SafeTouch IV Catheter (March 8, 2017)
  • K160444 — FB-U Hemodialyzer (February 8, 2017)
  • K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter (January 14, 2016)
  • K140191 — ELISIO-H HEMODIALYZER (April 14, 2014)
  • K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (February 14, 2014)

Other clearances for product code KDI

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  • 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)