510(k) · Cleared
ClearedHypothermx Intravenous Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emit Corporation · LGZ Warmer, Thermal, Infusion Fluid
Cleared on May 20, 2011 as substantially equivalent to K060537 (Enginivity, LLC, 2006) and 1 other predicate after a 143-day review. Its family tree reaches back 4 generations to 1977. 2 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- May 20, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K770232 (1977). 6 ancestors in all. No later device cites it as a predicate yet. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 3 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 2 generations backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- 1 generation backK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- This deviceK103801 Hypothermx Intravenous Fluid WarmerEmit Corporation · 2011
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −3 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −2 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| −1 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| 0 (this device) | K103801 | Hypothermx Intravenous Fluid Warmer | Emit Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 1 |
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.
2 devices in this family have 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 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? (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 |
|---|---|---|---|
| * | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Summary page 1…ravenous Fluid and Blood Warmer . Product Code: LGZ Classification: Unclassified Common Name: Fluid and Blood Warmer Predicate Devices: eFlow™ Model 100 1V Fluid Warmer (K060537) Thermal Angel™ Blood/Fluid Warmer Model 200 (K012031) Device Description: The HypothermXe Intravenous Fluid and Blood Warmer con… | 2006 |
| * | K012031 | Modification to Thermal AngelSummary page 1…assification: Unclassified Common Name: Fluid and Blood Warmer Predicate Devices: eFlow™ Model 100 1V Fluid Warmer (K060537) Thermal Angel™ Blood/Fluid Warmer Model 200 (K012031) Device Description: The HypothermXe Intravenous Fluid and Blood Warmer consists of a single unit that is placed between a standa… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 2006 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- 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 34 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K060537.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 HypothermX® is intended to warm blood blood products and intravenous solutions prior to administration. The HypothermX® is intended to be used by healthcare professionals in clinical and field environments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103801: Hypothermx Intravenous Fluid Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103801
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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