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510(k) K052253

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS by Gambro Renal Products — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2005
Date Received
August 18, 2005
Clearance Type
Special
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

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  • K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (May 2, 2013)
  • K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS) (December 14, 2012)
  • K120333 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY (May 25, 2012)
  • K110823 — PRISMAFLEX (June 17, 2011)
  • K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM (May 20, 2011)
  • K100451 — GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW (December 21, 2010)
  • K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (November 3, 2010)
  • K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (July 29, 2010)

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)