Name: Predicase
Price: 199 USD

K-number	K220935
Device name	Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
Applicant	Iren-Medical, Ltd.
Product code	FKX
Device class	Class II
Decision date	Dec 29, 2022
Decision	Substantially Equivalent
Regulation	876.5630

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 →

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

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