510(k) Report

FDA applicant

Nxstage Medical, Inc.

Lawrence, MA51 decisions2001–202451 recalls

FDA records 51 decisions for Nxstage Medical, Inc. (Lawrence, MA) from 2001 to 2024: 51 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 40 of them its own earlier devices. 51 recalls are linked to its devices, 7 Class I.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Nxstage Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007: 12008: 32009: 12010: 12011: 12012: 12013: 52014: 72015: 22017: 22018: 12019: 12023: 12024: 2
2007high 7 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

6in 2026

2007: 12011: 12013: 12014: 92015: 52017: 12018: 102019: 32024: 92025: 2, 1 Class I2026 (partial year): 6, 6 Class I
2007high 10 (2018) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Nxstage Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nxstage Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System26decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)6decisions
  • FKRSubsystem, Proportioning5decisions
  • FKPSystem, Dialysate Delivery, Single Patient4decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2decisions
  • ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2decisions

Also: FLA (1), FIE (1), KOC (1), FIP (1), LGZ (1), FII (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 135 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 188 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 75 predicates; 40 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 46 times; 40 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061837Nxstage Cartridge ExpressNxstage Medical, Inc. · 20064cite it
  • K080807Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. · 20083cite it
  • K141752Nxstage System OneNxstage Medical, Inc. · 20143cite it
  • K093069Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 20102cite it
  • K033386Nxstage Pureflow SolutionNxstage Medical, Inc. · 20032cite it
  • K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 20052cite it

What has FDA decided for it lately?

  • 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
  • K171331NxStage System OneNxstage Medical, Inc. · 2017
  • K170469NxStage System One PlusNxstage Medical, Inc. · 2017
  • K150472NxStage System OneNxstage Medical, Inc. · 2015

All 51 as Nxstage Medical, Inc. →

What has been recalled?

51 recalls linked to its devices; the latest:

  • K080807B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number…Mar 19, 2026Class I
  • K080807B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number…Mar 19, 2026Class I
  • K080807B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number…Mar 19, 2026Class I
  • K080807B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number…Mar 19, 2026Class I
  • K080807B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number…Mar 19, 2026Class I
  • K080807B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number…Mar 19, 2026Class I