510(k) · Cleared
ClearedModification to Nxstage 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 Jun 13, 2005 as substantially equivalent to K032356 (Nxstage Medical, Inc., 2003) after an 84-day review. Its family tree reaches back 4 generations to 1997. 5 later devices descend from it.
- Decided
- Jun 13, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955592 (1997). 7 ancestors in all, the oldest K923312 (1994). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
- 3 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
- 2 generations backK014152 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002
- 1 generation backK032356 Nxstage System One with Cartridge ExpressNxstage Medical, Inc. · 2003
- This deviceK050727 Modification to Nxstage Cartridge ExpressNxstage Medical, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK061837 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK232803 NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK183158 NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK131050 Nxstage 1.6M2 DialyzerNxstage Medical, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK123395 Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K061837Nxstage Cartridge ExpressNxstage Medical, Inc. · 2006 · cites it directly4descendants
- K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. · 2024 · 2 generations on0descendants
- K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019 · 2 generations on0descendants
- K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc. · 2013 · 2 generations on0descendants
- K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | 1997 | — |
| −3 | K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters | Gambro Healthcare | 1999 | — |
| −2 | K014152 | Nxstage Cartridge Express | Nxstage Medical, Inc. | 2002 | — |
| −1 | K032356 | Nxstage System One with Cartridge Express | Nxstage Medical, Inc. | 2003 | — |
| 0 (this device) | K050727 | Modification to Nxstage Cartridge Express | Nxstage Medical, Inc. | 2005 | — |
| +1 | K061837 | Nxstage Cartridge Express | Nxstage Medical, Inc. | 2006 | 1 |
| +2 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. | 2024 | — |
| +2 | K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | 2019 | 1 |
| +2 | K131050 | Nxstage 1.6M2 Dialyzer | Nxstage Medical, Inc. | 2013 | — |
| +2 | 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 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K032356 | Nxstage System One with Cartridge ExpressSummary page 2…has been performed to ensure that the modified device meets design specifications. The modified NxStage Cartridge Express has been compared to the baseline as cleared in K032356 and found to be substantially equivalent. Conclusion: Based on the device indications for use, comparison of descriptive and tec… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061837 | Nxstage Cartridge Express | 2006 | 4 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K061837 (Nxstage Medical, Inc., 2006) has gone furthest, with 4 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 hemofiltration, 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/K050727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050727: Modification to Nxstage 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/K050727
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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