510(k) · Cleared
Recalled · Class I · 2026Plum Duo™ Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FRN Pump, Infusion
Cleared on Aug 24, 2023 as substantially equivalent to K161469 (Hospira, Inc., 2017) after a 265-day review. Its family tree reaches back 7 generations to 2001. 10 of the 29 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Aug 24, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 6 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011442 (2001). 26 ancestors in all, the oldest K780880 (1978). 2 later devices descend from it, 2 citing it directly. 10 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 6 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 5 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 4 generations backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- 3 generations backK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- 2 generations backK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- 1 generation backK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
- This deviceK223607 Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242114 Plum Solo™ Precision IV PumpIcu Medical, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK242115 Plum Duo™ Precision IV PumpIcu Medical, Inc. · 2025 · Recalled
Class I recalls in this family
- K161469 Plum 360(TM) Infusion System with MedNet/ Smart…direct predicate · 2017
- K141789 Plum 360 Infusion System with Hospira Mednet…2 generations back · 2015
- K103224 Hospira Plum Infusion Set; Hospira Infusion Set…3 generations back · 2011
- K101677 Hospira Infusion Blood Sets3 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −6 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −5 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −4 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| −3 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| −2 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| −1 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| 0 (this device) | K223607 | Plum Duo™ Infusion System | Icu Medical, Inc. | 2023 | — |
| +1 | K242114 | Plum Solo™ Precision IV Pump | Icu Medical, Inc. | 2025 | 3 |
| +1 | K242115 | Plum Duo™ Precision IV Pump | Icu Medical, Inc. | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 3 | 1 |
| 2010 | 2 | 1 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
10 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleSummary page 4…eneration of the Plum™ family of devices that is based on the fundamental technology of the Plum 360™ Infusion System cleared under K161469. The pump design incorporates state-of-the-art features such as dual channel functionality,… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2026 | Class II | Z-2723-2026 | Under Investigation by firm | 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 | Software Design Change | 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 under- or over-delivery. |
| Dec 15, 2025 | Class II | Z-1118-2026 | Software design | 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 line container at the piggyback therapy… |
| Dec 15, 2025 | Class II | Z-1094-2026 | Nonconforming Material/Component | 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 produce audible alarms, alerts, or… |
| Jul 11, 2025 | Class I | Z-2129-2025 | Under Investigation by firm | 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 | Under Investigation by firm | 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 Library Manager (DLM) within the… |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 18 Class I recalls
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model…Hospira, Inc. · 2006 · 4 generations back · ◆ in the 2006 ancestors bar of FIG. 17 Class I recalls
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 12 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 20 of the 26 ancestors have a recall of any class; 9 have a Class I recall.
- Of its descendants, K242114 (Icu Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161469.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223607: Plum Duo™ Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223607
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026