Name: Predicase
Price: 199 USD

K-number	K233159
Device name	pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KPO
Device class	Class II
Decision date	Dec 1, 2023
Decision	Substantially Equivalent
Regulation	876.5820

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 →

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504

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