ClearanceBrief
510(k) K170110 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Diana Medication Transfer Set

ApplicantIcu Medical, Inc., San Clemente CA, US
DecisionSubstantially Equivalent, Aug 10, 2018
ReceivedJan 12, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K170110

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
ONBNone listed

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