510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150472Substantially Equivalent

NxStage System One

NxStage Medical Inc, Lawrence MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150472 is the FDA 510(k) clearance record for NxStage System One, a class II device, cleared for Nxstage Medical, Inc. on under FDA product code ODN (Ultrafiltration-Controlled Nocturnal Dialysate Delivery System). FDA's definition for product code ODN reads: "Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed...". FDA records list 51 510(k) clearances for Nxstage Medical, Inc., from to . As of , FDA records show no recalls naming K150472.

Clearance record

Decision date
Received
(101 days to decision)
Product code
ODN Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nxstage Medical, Inc. 350 Merrimack St., Lawrence MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODN

Trailing 12 months

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

FDA records show no clearances under product code ODN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODN, 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