ClearanceBrief
510(k) K253703 · FRN Pump, Infusion

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

ApplicantDeka R&D Corp, Manchester NH, US
DecisionSubstantially Equivalent, Jul 24, 2026
ReceivedNov 24, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253703

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.