510(k) Report

510(k) · Cleared

Cleared

Nxstage System One

K030470510(k) TraditionalCleared Jul 7, 2003145-day reviewClass II21 CFR 876.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nxstage Medical, Inc. · FII System, Dialysate Delivery, Sealed

Cleared on Jul 7, 2003 as substantially equivalent to K020858 (Nxstage Medical, Inc., 2002) and 2 other predicates after a 145-day review. Its family tree reaches back 3 generations to 2001. 29 later devices descend from it.

Decided
Jul 7, 2003
Review
145 days
Class
Class II
Product code
FII
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K001283 (2001). 7 ancestors in all, the oldest K872364 (1987). 29 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1987: 1 other ancestor1997: 1 other ancestor1991: 1 other ancestor2004: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2013: 6 descendants cleared2016: 1 descendant cleared2014: 2 descendants cleared2010: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2026: 3 descendants cleared2020: 3 descendants cleared2023: 1 descendant cleared2025: 3 descendants cleared2024: 1 descendant clearedK001283 · Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K012510 · Modification to: Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K020858 · Nxstage Therapy System · Nxstage Medical, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 6 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants K020858 · Nxstage Therapy System · Nxstage Medical, Inc. · 2002K012510 · Modification to: Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K001283 · Lifemate Hemofiltration System · Nxstage Medical, Inc. · 20010+5+10
  1. Root · 3 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  2. 2 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  3. 1 generation backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
  4. This deviceK030470 Nxstage System OneNxstage Medical, Inc. · 2003
  5. Descendant · cites it directly · 28 of its ownK041424 Nxstage System OneNxstage Medical, Inc. · 2004
  6. Descendant · 2 generations on · 27 of its ownK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
  7. Descendant · 3 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
  8. Descendant · 4 generations on · 20 of its ownK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
  9. Descendant · 4 generations on · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12008: 12009: 12010: 12013: 62014: 22015: 12016: 12017: 22020: 32023: 12024: 12025: 32026: 3
2004high 6 (2013) · low 0 (2007)2026

Most influential descendants

Showing 5 of 29 · See all
  • K041424Nxstage System OneNxstage Medical, Inc. · 2004 · cites it directly28descendants
  • K050525Nxstage System OneNxstage Medical, Inc. · 2005 · 2 generations on27descendants
  • K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 3 generations on26descendants
  • K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009 · 4 generations on20descendants
  • K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · 4 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001283Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−2K012510Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−1K020858Nxstage Therapy SystemNxstage Medical, Inc.2002—
0 (this device)K030470Nxstage System OneNxstage Medical, Inc.2003—
+1K041424Nxstage System OneNxstage Medical, Inc.2004—
+2K050525Nxstage System OneNxstage Medical, Inc.20052
+3K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation2006—
+4K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation2009—
+4K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America20083

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200810
200910
201010
201360
201420
201510
201610
201720
202030
202310
202410
202530
202630
FIG. 1 — Lineage of K030470, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FII? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K020858Nxstage Therapy System
Summary page 1
…sed NxStage System One is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA: 0 NxStage Therapy System (K020858, cleared 04/17/02) B. Braun Diapact CRRT (K973322, cleared 11/10/98) 0 Baxter (SPS), Model 550 (K872364, cl…
Nxstage Medical, Inc.2002—
*K973322Diapact CRRT
Summary page 1
…owing legally marketed predicate devices previously cleared by FDA: 0 NxStage Therapy System (K020858, cleared 04/17/02) B. Braun Diapact CRRT (K973322, cleared 11/10/98) 0 Baxter (SPS), Model 550 (K872364, cleared 10/13/87) Traditional 51O(k) Confidential === Page 2…
B.Braun Medical, Inc.1998—
*K872364Hemodialysis (SPS), Model 550, Code 5M1309
Summary page 1
…y FDA: 0 NxStage Therapy System (K020858, cleared 04/17/02) B. Braun Diapact CRRT (K973322, cleared 11/10/98) 0 Baxter (SPS), Model 550 (K872364, cleared 10/13/87) Traditional 51O(k) Confidential NxStage Medical, Inc.…
Travenol Laboratories, S.A.19872

Also cleared against K020858: 1 other device →

What descends from it? (29)

See all 29

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041424Nxstage System OneNxstage Medical, Inc.200428

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 9 months on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K041424 (Nxstage Medical, Inc., 2004) has gone furthest, with 28 descendants of its own.
  • 1 other device also cites its predicate K020858.

How does its category compare?

All FII devices

FII System, Dialysate Delivery, Sealed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FII

FDA has decided no FII device since 2007.

Median 510(k) review, days · FII

Too few FII 510(k)s in any year since 2007 to give a median.

Recalls per year · FII

No recall names FII since 2007.

Adverse event reports per year · FII

2in 2014

2007: 2042008: 1092009: 552010: 172012: 32013: 32014: 2
2007high 204 (2007) · low 0 (2011)2025

MAUDE reports naming product code FII, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0204
20080—0109
20090—055
20100—017
20110—00
20120—03
20130—03
20140—02
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

Indications for use as stated in the FDA summary.

Also cleared against K020858

1 other device cites the same predicate.

  • K071263Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 20071 recall

More from Nxstage Medical, Inc.

51 FDA decisions under this applicant name. See the company

  • K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024
  • K233213NxStage PureFlow SolutionNxstage Medical, Inc. · 2024
  • K230632VersiHD with GuideMe softwareNxstage Medical, Inc. · 2023
  • K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 20191 recall
  • K181991NxStage Connected Health SystemNxstage Medical, Inc. · 2018

Recent decisions in FII

The FII category page

  • K881270Gambro Multipurpose System MPS-10Gambro, Inc. · 1988
  • K872364Hemodialysis (SPS), Model 550, Code 5M1309Travenol Laboratories, S.A. · 19872 recalls
  • K862716Hemofiltration System 10Gambro, Inc. · 1986
  • K822386Cotral I W/4.5 L/HR. Ultrafiltrat. CapaHospal Medical Corp. · 1982

https://510kreport.com/device/K030470 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030470: Nxstage System One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030470

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026