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510(k) K122051

NXSTAGE SYSTEM ONE by Nxstage Medical, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2013
Date Received
July 12, 2012
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 Nxstage Medical, Inc.

  • K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (March 14, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K230632 — VersiHD with GuideMe software (August 11, 2023)
  • K183158 — NxStage Cartridge Express with Speedswap (August 9, 2019)
  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K171331 — NxStage System One (August 24, 2017)
  • K170469 — NxStage System One Plus (May 9, 2017)
  • K150472 — NxStage System One (June 4, 2015)
  • K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge (March 20, 2015)
  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)

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)