510(k) Report

510(k) · Cleared

Cleared

Nxstage Cartridge Express

K014152510(k) TraditionalCleared Dec 11, 2002358-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. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Dec 11, 2002 as substantially equivalent to K002210 (Baxter Healthcare Corp, 2001) and 3 other predicates after a 358-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.

Decided
Dec 11, 2002
Review
358 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K955592 (1997). 5 ancestors in all, the oldest K923312 (1994). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2003: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant cleared2013: 2 descendants clearedK955592 · Cobe Centrysystem 14 Pes Hemodialyzers · Cobe Renal Care, Inc. · 1997K982414 · Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters · Gambro Healthcare · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 4 descendants K982414 · Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters · Gambro Healthcare · 1999K955592 · Cobe Centrysystem 14 Pes Hemodialyzers · Cobe Renal Care, Inc. · 19970
  1. Root · 2 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
  2. 1 generation backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
  3. This deviceK014152 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002
  4. Descendant · cites it directly · 6 of its ownK032356 Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003
  5. Descendant · 2 generations on · 5 of its ownK050727 Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005
  6. Descendant · 3 generations on · 4 of its ownK061837 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · Recalled
  7. Descendant · 4 generations on · 0 of its ownK232803 NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024
  8. Descendant · 4 generations on · 0 of its ownK183158 NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12013: 22019: 12024: 1
2003high 2 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003 · cites it directly6descendants
  • K050727Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005 · 2 generations on5descendants
  • K061837Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · 3 generations on4descendants
  • K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024 · 4 generations on0descendants
  • K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K955592Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc.1997—
−1K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare1999—
0 (this device)K014152Nxstage Cartridge ExpressNxstage Medical, Inc.2002—
+1K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc.2003—
+2K050727Modification to Nxstage Cartridge ExpressNxstage Medical, Inc.2005—
+3K061837Nxstage Cartridge ExpressNxstage Medical, Inc.20061
+4K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc.2024—
+4K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc.20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
201320
201910
202410
FIG. 1 — Lineage of K014152, 1997–2024Source: 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 KDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KDI device

  1. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K002210Syntra Dialyzer, Model Syntra 120, 160Baxter Healthcare Corp2001—
*K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters
Summary page 1
…Dialyzer (Baxter Healthcare Corporation, KO02210), Cobe Arylane Hemodialyzer (Gambro Healthcare, K982414), RenofloB II Hemofilter (Minntech Corp, K923312) and to…
Gambro Healthcare1999—
*K923312High Permeability Dialyer
Summary page 1
…), Cobe Arylane Hemodialyzer (Gambro Healthcare, K982414), RenofloB II Hemofilter (Minntech Corp, K923312) and to the Prisma CFM System hemofilter (Hospal Renal In…
Minntech Corp.1994—
*K946279Prisma CFM (Continuous Fluid Management System)
Our reading of the summary gave K942679, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Prisma CFM System hemofilter”.
Cobe Renal Care, Inc.1997—

Also cleared against K002210: 2 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc.20036

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 5 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K032356 (Nxstage Medical, Inc., 2003) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K002210.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, 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
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

What is it indicated for?

The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.

Indications for use as stated in the FDA summary.

Also cleared against K002210

2 other devices cite the same predicate.

  • K160558Rapido Hollow-Fibre DialyzersBellco Srl · 2016
  • K023664Syntra + Dialyzer, Model 200Baxter Healthcare Corp · 2003

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 KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K014152 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014152: Nxstage Cartridge Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014152

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026