510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121421Substantially Equivalent

Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)

Fresenius Medical Care North America, Design Cente, Waltham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121421 is the FDA 510(k) clearance record for FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT), a class II device, cleared for Fresenius Medical Care North America, Design Cente 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 5 510(k) clearances for Fresenius Medical Care North America, Design Cente, from to . As of , FDA records show 2 recalls naming K121421.

Clearance record

Decision date
Received
(248 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, Design Cente 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