510(k) · Cleared
ClearedMaxone IV Fluid/Blood Warmer, Model 102
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 Jan 17, 2003 as substantially equivalent to K002409 (Automatic Medical Technologies, Inc., 2001) after a 79-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jan 17, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002409 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK002409 Maxone, Blood, Blood Products and IV Fluid WarmerAutomatic Medical Technologies, Inc. · 2001
- This deviceK023653 Maxone IV Fluid/Blood Warmer, Model 102Automatic Medical Technologies, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002409 | Maxone, Blood, Blood Products and IV Fluid Warmer | Automatic Medical Technologies, Inc. | 2001 | — |
| 0 (this device) | K023653 | Maxone IV Fluid/Blood Warmer, Model 102 | Automatic Medical Technologies, Inc. | 2003 | — |
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 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? (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 |
|---|---|---|---|
| * | K002409 | Maxone, Blood, Blood Products and IV Fluid WarmerSummary page 1…llj~Marketed Equivtrleiit Device Ncrnie: We are claiming substantial equivalence to the MaxOneTMIV Fluid/Blood Warmer, Model 101, cleared 5 1O(k) K002409. 1. Descripfion of the Device: The MaxOneTMIV Fluid/Blood Warmer consists of a single reusable heating ur,it… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K002409.
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 | — |
What is it indicated for?
The MaxOneTMIV Fluid/Blood Warmer, Model 102, is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023653: Maxone IV Fluid/Blood Warmer, Model 102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023653
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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