Plum Duo Precision IV Pump
FDA 510(k) K242115 · Icu Medical, Inc.
510(k) numberK242115
Submission
- Device name
- Plum Duo Precision IV Pump
- Applicant
- Icu Medical, Inc.
Lake Forest, IL, US - Received
- July 19, 2024
- Decision date
- April 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
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| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | 06/05/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
| K223607 | Plum Duo Infusion SystemFRN · Traditional | 08/24/2023SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | 08/24/2023SE |
Questions and answers
When was Plum Duo Precision IV Pump cleared by the FDA?
Plum Duo Precision IV Pump (K242115) received a 510(k) decision of Substantially Equivalent on April 2, 2025, 257 days after the submission was received.
What is the product code of K242115?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.