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510(k) K131611

FRESENIUS DRY ACID DISSOLUTION UNITS by Fresenius Medical Care North America — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2013
Date Received
June 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Fresenius Medical Care North America

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  • K162488 — Optiflux dialyzer (April 6, 2017)
  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K152367 — Optiflux dialyzer (October 29, 2015)
  • K123262 — OPTIFLUX ULTRA DIALYZER (January 6, 2014)
  • K124035 — 2008K@HOME HEMODIALYSIS MACHINE (July 3, 2013)
  • K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (December 6, 2012)
  • K120017 — FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (February 2, 2012)
  • K113427 — FRESENIUS 2008T HEMODIALYSIS MACHINE (December 21, 2011)
  • K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (February 3, 2011)

Other clearances for product code KPO

  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)