# K873435: Level 1 IR-600 Normothermic Irrigating Set

- Pathway: 510(k) (Traditional)
- Applicant: Level 1 Technologies, Inc.
- Decided: Oct 5, 1987 after 40 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has 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
- K060939: Ranger Irrigation Fluid Warming System (2006), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K873435
Methodology: https://510kreport.com/methodology