ClearanceBrief
510(k) K262532 · LGZ Warmer, Thermal, Infusion Fluid

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

ApplicantICU Medical, Lake Forest IL, US
DecisionSubstantially Equivalent, Sep 18, 2026
ReceivedJul 22, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K262532

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.