510(k) · Cleared
Recalled · Class I · 2014Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Aug 24, 2005 as substantially equivalent to K042081 (Hospira, Inc., 2004) and 3 other predicates after a 26-day review. Its family tree reaches back 3 generations to 2001. 9 of the 18 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 11 times, including a Class I recall.
- Decided
- Aug 24, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 11 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K011442 (2001). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly. 9 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 2 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 1 generation backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- This deviceK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
- Descendant · 4 generations on · 2 of its ownK223607 Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042081 Plum a+ Infusion System with Hospira Mednet…direct predicate · 2004
- K011442 Abbott Plum a+Infusion Pump, Model 11971direct predicate · 2001
- K103224 Hospira Plum Infusion Set; Hospira Infusion Set…cites it directly · 2011
- K070398 Hospira Plum a+ Infusion Pump, Model 12391cites it directly · 2007
Most influential descendants
Showing 5 of 12 · See all- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · cites it directly10descendants
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · 2 generations on9descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 3 generations on5descendants
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 4 generations on2descendants
- K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −2 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −1 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| 0 (this device) | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | — |
| +1 | 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 |
| +3 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| +4 | K223607 | Plum Duo™ Infusion System | Icu Medical, Inc. | 2023 | Class I |
| +3 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2011 | 1 | 1 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
9 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? (4)
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 |
|---|---|---|---|
| * | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with…Summary page 2…marized in the following table. Submissio History 510(k) TteDecision Date K042081 Plum A+ Infusion System with Hospira MedNetTM Software (v. 13.x) 08/24/2004 K024084 Abbott Plum A- Inf… | 2004 |
| * | K024084 | Abbott Plum a+ Infusion Pump, Model 12391Summary page 2…TteDecision Date K042081 Plum A+ Infusion System with Hospira MedNetTM Software (v. 13.x) 08/24/2004 K024084 Abbott Plum A- Infusion Pump, Model 12391 12/31/2002 K021350 Abbott Plum A+3 Mu… | 2002 |
| * | K021350 | Abbott Plum a+3 Multichannel Infusion Pump, Model 12348Summary page 2…with Hospira MedNetTM Software (v. 13.x) 08/24/2004 K024084 Abbott Plum A- Infusion Pump, Model 12391 12/31/2002 K021350 Abbott Plum A+3 Multichannel Infusion Pump 05/14/2002 K011442 Plum A+ Infusion P… | 2002 |
| * | K011442 | Abbott Plum a+Infusion Pump, Model 11971Summary page 2…Pump, Model 12391 12/31/2002 K021350 Abbott Plum A+3 Multichannel Infusion Pump 05/14/2002 K011442 Plum A+ Infusion Pump 6/05/2001 11. Comparison to Legally Marketed… | 2001 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2014 | Class I | Z-1075-2015 | Component change control | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. |
| Sep 9, 2013 | Class II | Z-2061-2016 | Device Design | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. |
| Feb 1, 2013 | Class II | Z-0288-2014 | Component design/selection | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and… |
| Dec 7, 2012 | Class II | Z-0625-2013 | Device Design | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. |
| Oct 26, 2012 | Class II | Z-0481-2013 | Device Design | The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a… |
| Feb 5, 2012 | Class II | Z-0208-2014 | Nonconforming Material/Component | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186… |
| Sep 16, 2011 | Not classified | Z-0010-2012 | Software design | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This… |
| Sep 16, 2011 | Not classified | Z-3285-2011 | Nonconforming Material/Component | Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged… |
| Feb 14, 2011 | Not classified | Z-1645-2011 | Nonconforming Material/Component | Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. |
| Nov 24, 2009 | Not classified | Z-1349-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Aug 11, 2009 | Not classified | Z-0026-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
The 5 latest of 11 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.
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K070398Hospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 14 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 on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K103224 (Hospira, Inc., 2011) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K042081.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052052: Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052052
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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