510(k) · Cleared
Recalled · Class II · 2026Hotline Fluid Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Level 1 Technologies, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Oct 17, 1991 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 18 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it. It has been recalled 11 times.
- Decided
- Oct 17, 1991
- Review
- 203 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 11
- Predicates
- 0
17 later devices descend from it, 2 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- This deviceK911383 Hotline Fluid WarmerLevel 1 Technologies, Inc. · 1991
- Descendant · cites it directly · 16 of its ownK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- Descendant · cites it directly · 13 of its ownK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 12 of its ownK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- Descendant · 4 generations on · 1 of its ownK232107 °M Warmer SystemMequ A/S · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K984640Thermal AngelEstill Medical Technologies, Inc. · 1999 · cites it directly16descendants
- K012031Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · cites it directly13descendants
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Enginivity, LLC · 2006 · 2 generations on12descendants
- K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012 · 3 generations on10descendants
- K232107°M Warmer SystemMequ A/S · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911383 | Hotline Fluid Warmer | Level 1 Technologies, Inc. | 1991 | — |
| +1 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| +1 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| +2 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| +3 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| +4 | K232107 | °M Warmer System | Mequ A/S | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2026 | Class II | Z-2759-2026 | Process control | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. |
| Mar 17, 2014 | Class II | Z-1444-2014 | Nonconforming Material/Component | Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged |
| Mar 17, 2014 | Class II | Z-1443-2014 | Nonconforming Material/Component | Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged. |
| Jun 27, 2012 | Class II | Z-1979-2012 | Device Design | HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable |
| Nov 21, 2011 | Not classified | Z-0424-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
| Nov 21, 2011 | Not classified | Z-0425-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
| Nov 21, 2011 | Not classified | Z-0423-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
| Nov 21, 2011 | Not classified | Z-0427-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
| Nov 21, 2011 | Not classified | Z-0422-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
| Nov 21, 2011 | Not classified | Z-0428-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
| Nov 21, 2011 | Not classified | Z-0426-2012 | Device Design | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
The 5 latest of 11 recalls; the web page lists all.
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 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
- K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K984640 (Estill Medical Technologies, Inc., 1999) has gone furthest, with 16 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/K911383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911383: Hotline 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/K911383
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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