ClearanceBrief
510(k) K253068 · FMF Syringe, Piston

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

ApplicantCMT Health PTE., Ltd., Singapore, SG
DecisionSubstantially Equivalent, Feb 23, 2026
ReceivedSep 22, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253068

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.