510(k) · Cleared
Recalled · Class II · 2024NxStage Cartridge Express with Speedswap
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 Aug 9, 2019 as substantially equivalent to K061837 (Nxstage Medical, Inc., 2006) after a 267-day review. Its family tree reaches back 6 generations to 1997. It has been recalled once.
- Decided
- Aug 9, 2019
- Review
- 267 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K955592 (1997). 9 ancestors in all, the oldest K923312 (1994). No later device cites it as a predicate yet.
- 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 deviceK183158 NxStage Cartridge Express with SpeedswapNxstage Medical, Inc. · 2019
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) | K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K061837 | Nxstage Cartridge ExpressSummary page 5…5 Traditional 510(k) Premarket Notification Predicate Device: The predicate device is the currently marketed NxStage System One Cartridge Express, K061837 FDA cleared on July 31, 2006. Substantial Equivalence: The NxStage Cartridge Express with Speedswap has the same intended use a… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2024 | Class II | Z-1191-2024 | Component design/selection | Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 3 other devices also cite its predicate K061837.
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. 2019, this device’s year, is highlighted.
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 the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute care facility. The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid…
Read the full statement (116 words)
The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute care facility.
The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload. The device would be used when hemofiltration, hemodialysis, and /or ultrafiltration may become disrupted.
All treatments must be administered under a physician’s prescription and must be observed 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/K183158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183158: NxStage Cartridge Express with Speedswap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183158
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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