Plum Duo™ Infusion System
FDA 510(k) clearance K223607 · decided 2023-08-24
Clearance details
- K-number
- K223607
- Device name
- Plum Duo™ Infusion System
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-02
- Decision date
- 2023-08-24
- Days to decision
- 265 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 Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 40 recall (Z-2723-2026) | ICU Medical, Inc. | 2026-07-10 |
| Plum Duo Infusion Pump, 40002-0401 recall (Z-2312-2026) | ICU Medical, Inc. | 2026-06-05 |
| ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) recall (Z-1118-2026) | ICU Medical, Inc. | 2026-01-16 |
| Plum Duo Infusion System, List Number 40002-04-01 recall (Z-1094-2026) | ICU Medical, Inc. | 2026-01-15 |
| Plum Duo Infusion System, List Number: 400020401 recall (Z-2129-2025) | ICU Medical, Inc. | 2025-08-06 |
| ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusio recall (Z-1990-2025) | ICU Medical, Inc. | 2025-06-18 |