510(k) K242114 · FRN Pump, Infusion
Plum Solo Precision IV Pump
| Applicant | Icu Medical, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Apr 2, 2025 |
| Received | Jul 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | ICU Medical, Inc. ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump Open, Classified |
FRN | None listed |
| Jun 5, 2026 | ICU Medical, Inc. Plum Solo Precision IV Pump, 40001-0401 Open, Classified |
FRN | None listed |
| Jan 16, 2026 | ICU Medical, Inc. ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.