FDA 510(k)

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

K-Number: K242269 · 2024-11-01

ApplicantQuanta Dialysis Technologies, Ltd.

Decision Date2024-11-01

Product CodeONW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is a medical device manufactured by Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2024-11-01 under approval number K242269. The device is classified under product code ONW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Quanta Dialysis Technologies, Ltd.. The 510(k) number is K242269.

When was SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) approved by the FDA?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) received FDA 510(k) clearance on 2024-11-01, under approval number K242269.

What company makes SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is manufactured by Quanta Dialysis Technologies, Ltd..

What is the FDA product code for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)?

The FDA product code for SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) is ONW.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Quanta Dialysis Technologies, Ltd.

K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.