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510(k) K242269

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) by Quanta Dialysis Technologies, Ltd. — Product Code ONW

K242269 is an FDA 510(k) premarket notification submitted by Quanta Dialysis Technologies, Ltd. for the device "SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code ONW (Hemodialysis System For Home Use), a Class II device regulated under 21 CFR 876.5860. Quanta Dialysis Technologies, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
August 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialysis System For Home Use
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

To treat and provide hemodialysis therapy at home for chronic renal failure patients.

Other clearances by Quanta Dialysis Technologies, Ltd.

  • K222067 — SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set (November 10, 2022)
  • K210661 — SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset (August 12, 2021)
  • K193670 — SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set (December 23, 2020)

Other clearances for product code ONW

  • K124035 — 2008K@HOME HEMODIALYSIS MACHINE (July 3, 2013)
  • K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALE (January 17, 2013)
  • K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (February 3, 2011)

FDA data resources