# K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jun 2, 2008 after 308 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K873435 (1987). 5 ancestors in all.
7 later devices descend from it; 4 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936223: Pressure Irrigating System, Level 1 Technologies, Inc. (1994) Summary page 4.
- K873435: Level 1 IR-600 Normothermic Irrigating Set, Level 1 Technologies, Inc. (1987) Summary page 4.
- K060939: Ranger Irrigation Fluid Warming System, Arizant Healthcare, Inc. (2006) Summary page 4.

## Most influential descendants
- K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000 (2010), 4 descendants of its own
- K133799: Thermedx Fluid Managment System (2014), 3 descendants of its own
- K172048: FluidSmart (2017), 2 descendants of its own
- K262532: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (2026), 0 descendants of its own
- K251273: Asurys Fluid Management System (2026), 0 descendants of its own

## Recalls of this device
- Aug 6, 2021 · Class I · Z-2377-2021: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
- Aug 6, 2021 · Class I · Z-2376-2021: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

## Indications for use
The Level 1® NORMOFLO® Irrigation Warming Set (Disposable Set) is a disposable irrigating fluid administration set, designed for use by trained medical professionals, for warming irrigating fluids. The Disposable Set is intended for use with the Level 1® H-1100 series NORMOFLO® Irrigation Fluid Warmers only.

Source page: https://510kreport.com/device/K072080
Methodology: https://510kreport.com/methodology