# K210661: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

- Pathway: 510(k) (Traditional)
- Applicant: Quanta Dialysis Technologies, Ltd.
- Decided: Aug 12, 2021 after 161 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921456 (1994). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193670: SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set, Quanta Dialysis Technologies, Ltd. (2020) Summary page 5.

## Most influential descendants
- K242269: SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (2024), 0 descendants of its own
- K222067: SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set (2022), 0 descendants of its own

## Indications for use
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription, by a trained person who is considered competent in the use of the device. The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.

Source page: https://510kreport.com/device/K210661
Methodology: https://510kreport.com/methodology