# K223607: Plum Duo™ Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Aug 24, 2023 after 265 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011442 (2001). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
10 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module, Hospira, Inc. (2017) Summary page 4.

## Most influential descendants
- K242114: Plum Solo™ Precision IV Pump (2025), 0 descendants of its own
- K242115: Plum Duo™ Precision IV Pump (2025), 0 descendants of its own

## Recalls of this device
- Jun 10, 2026 · Class II · Z-2723-2026: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Apr 29, 2026 · Class II · Z-2312-2026: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to
- Dec 15, 2025 · Class II · Z-1118-2026: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary l
- Dec 15, 2025 · Class II · Z-1094-2026: ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not pr
- Jul 11, 2025 · Class I · Z-2129-2025: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- Apr 22, 2025 · Class II · Z-1990-2025: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug L

## Indications for use
The Plum Duo Infusion System is intended for parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies). The Plum Duo Infusion System is intended for use in clinical environments in the hospital environment and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Duo Infusion System is intended for adult, pediatric (including infants and children), and neonatal patient populations.

Source page: https://510kreport.com/device/K223607
Methodology: https://510kreport.com/methodology