K242114 is an FDA 510(k) clearance for the Plum Solo™ Precision IV Pump. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 2, 2025, 257 days after receiving the submission on July 19, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K242114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2024 |
| Decision Date | April 02, 2025 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |