510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K124035Substantially Equivalent

2008K@home Hemodialysis Machine

Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K124035 is the FDA 510(k) clearance record for 2008K@HOME HEMODIALYSIS MACHINE, a class II device, cleared for Fresenius Medical Care North America on under FDA product code ONW (Hemodialysis System For Home Use). FDA's definition for product code ONW reads: "To treat and provide hemodialysis therapy at home for chronic renal failure patients". FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show no recalls naming K124035.

Clearance record

Decision date
Received
(187 days to decision)
Product code
ONW Hemodialysis System For Home Use
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius Medical Care North America 920 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONW

Trailing 12 months

FDA records hold no clearances under product code ONW in the trailing twelve months.

FDA records show no clearances under product code ONW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260