# K262532: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

- Pathway: 510(k) (Traditional)
- Applicant: ICU Medical
- Decided: Sep 18, 2026 after 58 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K873435 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,, Smiths Medical Asd, Inc. (2008) Summary page 5.

## Indications for use
The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for the administration of warmed irrigating fluids. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with NORMOFLO™ Irrigation Fluid Warmers only. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with adult patients.

Source page: https://510kreport.com/device/K262532
Methodology: https://510kreport.com/methodology