510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONWClass II

Hemodialysis System For Home Use

21 CFR 876.5860 / Gastroenterology, Urology
FDA source (opens on fda.gov)

ONW is the FDA product code for Hemodialysis System For Home Use, a class II device type, regulated under 21 CFR 876.5860. FDA's definition for this code reads: "To treat and provide hemodialysis therapy at home for chronic renal failure patients". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ONW
Device name
Hemodialysis System For Home Use
FDA definition
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
4

Clearances, product code ONW

By decision year
4 clearances under product code ONW with a decision year between 2011 and 2024, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ONW by decision year
YearClearances
20111
20132
20241

Applicants with the most clearances

Product code ONW
Applicants holding the most 510(k) clearances under product code ONW
ApplicantClearances
Fresenius Medical Care Renal Therapies Group, LLC2
Fresenius Medical Care North America, Design Cente1
Quanta Dialysis Technologies Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code