# K060939: Ranger Irrigation Fluid Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Arizant Healthcare, Inc.
- Decided: Jun 26, 2006 after 81 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873435 (1987). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973741: Bair Hugger Blood/Fluid Warmer, Augustine Medical, Inc. (1998) Summary page 4.
- K933726: Modification of Bair Hugger Patient Warming System, Augustine Medical, Inc. (1994) Summary page 4.
- K873435: Level 1 IR-600 Normothermic Irrigating Set, Level 1 Technologies, Inc. (1987) Summary page 4.

## Most influential descendants
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600, (2008), 7 descendants of its own
- 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

## Recalls of this device
- Apr 22, 2025 · Class II · Z-2231-2025: Notice was issued to clarify flow rates related to the inlet fluid temperature.

## Indications for use
The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

Source page: https://510kreport.com/device/K060939
Methodology: https://510kreport.com/methodology