Name: Predicase
Price: 199 USD

K-number	K210661
Device name	SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
Applicant	Quanta Dialysis Technologies, Ltd.
Product code	KDI
Device class	Class II
Decision date	Aug 12, 2021
Decision	Substantially Equivalent
Regulation	876.5860

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Everything you need for a 510(k) submission. Nothing you don't.