510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030470Substantially Equivalent

Nxstage System One

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

K030470 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 FII (System, Dialysate Delivery, Sealed). FDA records list 51 510(k) clearances for Nxstage Medical, Inc., from to . As of , FDA records show no recalls naming K030470.

Clearance record

Decision date
Received
(145 days to decision)
Product code
FII System, Dialysate Delivery, Sealed
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nxstage Medical, Inc. 439 S. Union St. Suite 501, Lawrence MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FII

Trailing 12 months

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

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