510(k) clearance
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
- 510(k) number
- K262532
- Applicant
- ICU Medical
- Decision date
- Sep 18, 2026
- Date received
- Jul 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LGZ
- Device type
- Warmer, Thermal, Infusion Fluid
- Device class
- Class II
- Regulation
- 21 CFR 880.5725
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Lake Forest, IL, US