# K242114: Plum Solo™ Precision IV Pump

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Apr 2, 2025 after 257 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K011442 (2001). 27 ancestors in all.
No later device cites it as a predicate yet.
10 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223607: Plum Duo™ Infusion System, Icu Medical, Inc. (2023) Summary page 5.

## Recalls of this device
- Jun 10, 2026 · Class II · Z-2724-2026: 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-2311-2026: 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-1120-2026: 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

## Indications for use
The Plum Solo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Solo™ Precision IV Pump is intended for use in clinical environments in the hospital 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 Solo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

Source page: https://510kreport.com/device/K242114
Methodology: https://510kreport.com/methodology