510(k) · Cleared
Recalled · Class II · 2018Nxstage Travel Warmer, Models TW-400 & FWS-500
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 24, 2007 as substantially equivalent to K012832 (Nxstage Medical, Inc., 2001) and 1 other predicate after a 109-day review. Its family tree reaches back 3 generations to 2001. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 24, 2007
- Review
- 109 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001283 (2001). 6 ancestors in all, the oldest K973741 (1998). 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 2 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 1 generation backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- This deviceK071263 Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK140623 Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014
Class I recalls in this family
- K973741 Bair Hugger Blood/Fluid Warmer2 generations back · 1998
Most influential descendants
Showing 1 of 1 · See all- K140623Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −2 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −1 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| 0 (this device) | K071263 | Nxstage Travel Warmer, Models TW-400 & FWS-500 | Nxstage Medical, Inc. | 2007 | — |
| +1 | K140623 | Nxstage Express Fluid Warmer | Nxstage Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K012832 | Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable…Summary page 1…t Code: 78 FLA C. Substantial Equivalence/Predicate Devices: The proposed NxStage Travel Warmer is substantially equivalent to the NxStage Warmer cleared through K012832 on 10/24/2001 and K020858 on 4/17/2002. D. Device Description/Indications for Use: The NxStage Travel Warmer and Travel Warme… | 2001 |
| * | K020858 | Nxstage Therapy SystemSummary page 1…ntial Equivalence/Predicate Devices: The proposed NxStage Travel Warmer is substantially equivalent to the NxStage Warmer cleared through K012832 on 10/24/2001 and K020858 on 4/17/2002. D. Device Description/Indications for Use: The NxStage Travel Warmer and Travel Warmer Disposable Set are acces… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140623 | Nxstage Express Fluid Warmer | 2014 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2018 | Class II | Z-2793-2018 | Use error | There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K140623 (Nxstage Medical, Inc., 2014) has gone furthest, with 0 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. 2007, 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 Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate prior to administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071263: Nxstage Travel Warmer, Models TW-400 & FWS-500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071263
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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