ClearanceBrief
510(k) K252500 ยท OWB Interventional Fluoroscopic X-Ray System

CARA System

ApplicantCara Medical, Ltd., Rd. Town, VG
DecisionSubstantially Equivalent, Feb 20, 2026
ReceivedAug 8, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252500

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.