510(k) · Cleared

Cleared

Nxstage System One Low Volume Cartridge Express

K123395510(k) TraditionalCleared Mar 7, 2013122-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 Mar 7, 2013 as substantially equivalent to K061837 (Nxstage Medical, Inc., 2006) and 4 other predicates after a 122-day review. Its family tree reaches back 6 generations to 1997.

Decided: Mar 7, 2013
Review: 122 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K955592 (1997). 18 ancestors in all, the oldest K923312 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
5 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
4 generations backK014152 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002
3 generations backK032356 Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003
2 generations backK050727 Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005
1 generation backK061837 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · Recalled
This deviceK123395 Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K955592	Cobe Centrysystem 14 Pes Hemodialyzers	Cobe Renal Care, Inc.	1997	—
−5	K982414	Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters	Gambro Healthcare	1999	—
−4	K014152	Nxstage Cartridge Express	Nxstage Medical, Inc.	2002	—
−3	K032356	Nxstage System One with Cartridge Express	Nxstage Medical, Inc.	2003	—
−2	K050727	Modification to Nxstage Cartridge Express	Nxstage Medical, Inc.	2005	—
−1	K061837	Nxstage Cartridge Express	Nxstage Medical, Inc.	2006	1
0 (this device)	K123395	Nxstage System One Low Volume Cartridge Express	Nxstage Medical, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1996	1	0
1997	1	0
1998	2	0
1999	1	0
2001	1	0
2003	1	0
2006	1	0
2007	1	0
2010	1	0

FIG. 1 — Lineage of K123395, 1997–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K061837	Nxstage Cartridge Express Summary page 3 …Disposable Set Express, Express - Blood Set Low K032431 -K061837 Weight Low Volume _…	Nxstage Medical, Inc.	2006	1
*	K100364	Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520 Summary page 2 …DB) D. Predicate Devices: NxStage Cartridge Express K061 387 Gambro Cartridge Blood Set Low Weight - Low Volume Set K100364 Gambro Prisma M60 Set K032431 Minntech HF Junior Hemofilter…	Gambro Renal Products, Inc.	2010	5
*	K032431	Prisma M60/M100 Sets Summary page 2 …K061 387 Gambro Cartridge Blood Set Low Weight - Low Volume Set K100364 Gambro Prisma M60 Set K032431 Minntech HF Junior Hemofilter K071 298 Minntech High Permeability Dialyzer…	Gambro, Inc.	2003	6
*	K071298	HF Junior Hemofilter Summary page 2 …Volume Set K100364 Gambro Prisma M60 Set K032431 Minntech HF Junior Hemofilter K071 298 Minntech High Permeability Dialyzer K923312 E. Substantial Equivalence: The NxStage System One…	Minntech Corp.	2007	—
*	K923312	High Permeability Dialyer Summary page 2 …K032431 Minntech HF Junior Hemofilter K071 298 Minntech High Permeability Dialyzer K923312 E. Substantial Equivalence: The NxStage System One Low Volume Cartridge Express device is substantially equivalent in desig…	Minntech Corp.	1994	—

Also cleared against K061837: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
5 of the 18 ancestors have a recall of any class.
3 other devices also cite its predicate K061837.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · KDI

9in 2025

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

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

Recalls per year · KDI

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	91	4	916
2008	6	148	0	1,042
2009	4	236	3	522
2010	9	186	1	823
2011	5	85	4	2,270
2012	6	153	1	1,765
2013	11	247	2	2,360
2014	8	164	3	6,154
2015	5	69	5	4,182
2016	5	230	4	766
2017	8	188	1	963
2018	2	—	1	1,716
2019	4	263	6	1,587
2020	9	266	0	1,633
2021	2	—	2	1,944
2022	7	259	17	2,180
2023	7	157	8 (8)	2,692
2024	7	235	4 (2)	2,441
2025	9	199	2	2,786
2026	6	154	2	—

What is it indicated for?

The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit, It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.

All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123395 · printed Nov 4, 2026

Cite this page

510(k) Report. “K123395: Nxstage System One Low Volume Cartridge Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123395

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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