Plum Solo™ Precision IV Pump
FDA 510(k) clearance K242114 · decided 2025-04-02
Clearance details
- K-number
- K242114
- Device name
- Plum Solo™ Precision IV Pump
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-19
- Decision date
- 2025-04-02
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump recall (Z-2724-2026) | ICU Medical, Inc. | 2026-07-10 |
| Plum Solo Precision IV Pump, 40001-0401 recall (Z-2311-2026) | ICU Medical, Inc. | 2026-06-05 |
| ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippi recall (Z-1120-2026) | ICU Medical, Inc. | 2026-01-16 |