FDA 510(k)

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

K-Number: K222067 · 2022-11-10

ApplicantQuanta Dialysis Technologies, Ltd.

Decision Date2022-11-10

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device manufactured by Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2022-11-10 under approval number K222067. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Quanta Dialysis Technologies, Ltd.. The 510(k) number is K222067.

When was SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set approved by the FDA?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set received FDA 510(k) clearance on 2022-11-10, under approval number K222067.

What company makes SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is manufactured by Quanta Dialysis Technologies, Ltd..

What is the FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is KDI.

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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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 28114192 FDA Benchmark Medical Device Flow Models for CFD Validation. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2017)

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 K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.

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.