510(k) · Cleared
ClearedMaxone, Blood, Blood Products and IV Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Automatic Medical Technologies, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jun 28, 2001 after a 325-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 28, 2001
- Review
- 325 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK002409 Maxone, Blood, Blood Products and IV Fluid WarmerAutomatic Medical Technologies, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK012832 Comfortmate Fluid Warming System, Model # FW-200; Comfortmate…Nxstage Medical, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK071263 Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK060851 Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2…The Smithworks Company · 2006
- Descendant · 3 generations on · 0 of its ownK140623 Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK120860 Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K012832Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable…Nxstage Medical, Inc. · 2001 · cites it directly2descendants
- K071263Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc. · 2007 · 2 generations on1descendant
- K060851Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the…The Smithworks Company · 2006 · cites it directly1descendant
- K140623Nxstage Express Fluid WarmerNxstage Medical, Inc. · 2014 · 3 generations on0descendants
- K120860Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002409 | Maxone, Blood, Blood Products and IV Fluid Warmer | Automatic Medical Technologies, Inc. | 2001 | — |
| +1 | K012832 | Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable… | Nxstage Medical, Inc. | 2001 | — |
| +2 | K071263 | Nxstage Travel Warmer, Models TW-400 & FWS-500 | Nxstage Medical, Inc. | 2007 | 1 |
| +1 | K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer… | The Smithworks Company | 2006 | — |
| +3 | K140623 | Nxstage Express Fluid Warmer | Nxstage Medical, Inc. | 2014 | — |
| +2 | K120860 | Infu Box Type 0412A | Medical Rescue Equipment Holding AS | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGZ? 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 LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012832 (Nxstage Medical, Inc., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, 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 | 2 | — | 0 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K002409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002409: Maxone, Blood, Blood Products and IV Fluid Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002409
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026