510(k) · Cleared
ClearedNxstage Express Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · FLA Monitor, Temperature, Dialysis
Cleared on Jun 16, 2014 as substantially equivalent to K071263 (Nxstage Medical, Inc., 2007) after a 97-day review. Its family tree reaches back 4 generations to 2001. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 16, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- FLA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001283 (2001). 7 ancestors in all, the oldest K973741 (1998). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 3 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 2 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 1 generation backK071263 Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 2007 · Recalled
- This deviceK140623 Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014
Class I recalls in this family
- K973741 Bair Hugger Blood/Fluid Warmer3 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −3 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −2 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −1 | K071263 | Nxstage Travel Warmer, Models TW-400 & FWS-500 | Nxstage Medical, Inc. | 2007 | 1 |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K071263 | Nxstage Travel Warmer, Models TW-400 & FWS-500Summary page 2…C. Substantial Equivalence/Predicate Devices: The proposed NxStage Express Fluid Warmer is substantially equivalent to the NxStage Travel Warmer cleared through K071263 on August 24, 2007. D. Device Description/indications for Use: The NxStage Express Fluid Warmer is an accessory to the NxStag… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FLA devicesFLA Monitor, Temperature, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FLA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FLA
Too few FLA 510(k)s in any year since 2007 to give a median.
Recalls per year · FLA
No recall names FLA since 2007.
Adverse event reports per year · FLA
No MAUDE report names FLA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140623: Nxstage Express Fluid Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140623
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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