# K242269: SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

- Pathway: 510(k) (Traditional)
- Applicant: Quanta Dialysis Technologies, Ltd.
- Decided: Nov 1, 2024 after 92 days
- Product code: ONW (Hemodialysis System For Home Use)
- 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: 10 generations back to K921456 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210661: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset, Quanta Dialysis Technologies, Ltd. (2021) Summary page 6.

## 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 clinician who is competent in the use of the device. The SC+ Hemodialysis System is also indicated for use in the home by trained patients in tandem with a trained care partner. The SC+ Blood Tube Set 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/K242269
Methodology: https://510kreport.com/methodology