ClearanceBrief
510(k) K242115 · FRN Pump, Infusion

Plum Duo™ Precision IV Pump

ApplicantIcu Medical, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Apr 2, 2025
ReceivedJul 19, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242115

DateFirm and productCodeLinked 510(k)
Jun 5, 2026ICU Medical, Inc.
Plum Duo Precision IV Pump, 40002-0403
Open, Classified
FRNNone listed
Jan 16, 2026ICU Medical, Inc.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Open, Classified
FRNNone listed

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