# K911383: Hotline Fluid Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Level 1 Technologies, Inc.
- Decided: Oct 17, 1991 after 203 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984640: Thermal Angel (1999), 16 descendants of its own
- K012031: Modification to Thermal Angel (2001), 13 descendants of its own
- K060537: Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120 (2006), 12 descendants of its own
- K112902: Enflow IV Fluid Warmer (2012), 10 descendants of its own
- K232107: °M Warmer System (2024), 1 descendant of its own

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2759-2026: 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 b
- Mar 17, 2014 · Class II · Z-1444-2014: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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

Source page: https://510kreport.com/device/K911383
Methodology: https://510kreport.com/methodology