510(k) · Cleared
ClearedNxstage System One with Cartridge Express
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Oct 28, 2003 as substantially equivalent to K014152 (Nxstage Medical, Inc., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Oct 28, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955592 (1997). 6 ancestors in all, the oldest K923312 (1994). 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 2 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- 1 generation backK014152 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002
- This deviceK032356 Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK050727 Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK061837 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 0 of its ownK232803 NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK183158 NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK131050 Nxstage 1.6M2 DialyzerNxstage Medical, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K050727Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005 · cites it directly5descendants
- K061837Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · 2 generations on4descendants
- K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024 · 3 generations on0descendants
- K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019 · 3 generations on0descendants
- K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −2 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| −1 | K014152 | Nxstage Cartridge Express | Nxstage Medical, Inc. | 2002 | — |
| 0 (this device) | K032356 | Nxstage System One with Cartridge Express | Nxstage Medical, Inc. | 2003 | — |
| +1 | K050727 | Modification to Nxstage Cartridge Express | Nxstage Medical, Inc. | 2005 | — |
| +2 | K061837 | Nxstage Cartridge Express | Nxstage Medical, Inc. | 2006 | 1 |
| +3 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. | 2024 | — |
| +3 | K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | 2019 | 1 |
| +3 | K131050 | Nxstage 1.6M2 Dialyzer | Nxstage Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K014152 | Nxstage Cartridge ExpressSummary page 2…in design and configuration as compared to the predicate devices. There are no material changes to the NxStage Cartridge Express as described and cleared through K014152, as a result of this 510(k) submission. The only difference between the proposed Cartridge Express as compared to the predica… | 2002 |
| * | K946279 | Prisma CFM (Continuous Fluid Management System)Summary page 1…marketed predicate devices previously cleared by FDA: NxStage Cartridge Express (KO14152, cleared 12/10/02) 0 Gambro Prisma CFM System Disposable Tubing Set (K946279, cleared 02/10/97) Traditional 51O(k) Confidential… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050727 | Modification to Nxstage Cartridge Express | 2005 | 5 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K050727 (Nxstage Medical, Inc., 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KDI devicesKDI 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 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 is indicated for treatment of renal failure or fluid overload using hernofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician’s prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032356: Nxstage System One with Cartridge Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032356
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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