510(k) · Cleared
Recalled · Class I · 2024Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software
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, 2004 as substantially equivalent to K031185 (Abbott Laboratories, 2003) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 2001. 12 of the 32 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it. It has been recalled 19 times, including 4 Class I recalls.
- Decided
- Aug 24, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 19 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011442 (2001). 4 ancestors in all. 27 later devices descend from it, 6 citing it directly. 12 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 1 generation backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- This deviceK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004
- Descendant · cites it directly · 12 of its ownK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 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 · cites it directly · 4 of its ownK042609 Hospira Mednet Medication Management SuiteHospira, Inc. · 2004 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
2004high 3 (2004) · low 0 (2006)2026
Class I recalls in this family
- K011442 Abbott Plum a+Infusion Pump, Model 119712 generations back · 2001
- K081412 Plum a+ Hyperbaric Infusion System with Hospira…cites it directly · 2008
- K052052 Hospira Plum a+ Infusion Pump System V11.5…cites it directly · 2005
- K141789 Plum 360 Infusion System with Hospira Mednet…cites it directly · 2015
Most influential descendants
Showing 5 of 27 · See all- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · cites it directly12descendants
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations on10descendants
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · cites it directly9descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on5descendants
- K042609Hospira Mednet Medication Management SuiteHospira, Inc. · 2004 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −1 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| 0 (this device) | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | — |
| +1 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| +2 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| +1 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +2 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| +1 | K042609 | Hospira Mednet Medication Management Suite | Hospira, Inc. | 2004 | 1 |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 1 |
| 2007 | 1 | 1 |
| 2008 | 2 | 2 |
| 2011 | 1 | 1 |
| 2014 | 2 | 0 |
| 2015 | 1 | 1 |
| 2016 | 2 | 0 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2025 | 3 | 0 |
| 2026 | 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.
12 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? (2)
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 |
|---|---|---|---|
| * | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleSummary page 1…Software 5. Predicate Devices: Abbott Plum A+® Infusion Pump with HPL/RS Plug-and- Play Module (K031185) Abbott Plum A+3 MT Multichannel Infusion Pump (K021350) 6. Proposed Device Description:… | 2003 |
| * | K021350 | Abbott Plum a+3 Multichannel Infusion Pump, Model 12348Summary page 1…sion Pump with HPL/RS Plug-and- Play Module (K031185) Abbott Plum A+3 MT Multichannel Infusion Pump (K021350) 6. Proposed Device Description: The Plum A+® and A+®3 Infusion Systems with MedNet M T… | 2002 |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5 Class I | 2005 | 12 |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for… Class I | 2015 | 9 |
| K042609 | Hospira Mednet Medication Management Suite | 2004 | 4 |
| K141389 | Sapphire Infusion Pump | 2014 | 3 |
| K042800 | Lifecare Pca Infusion System with Hospira Mednet Software | 2004 | 3 |
| K081412 | Plum a+ Hyperbaric Infusion System with Hospira Mednet Software Class I | 2008 | 0 |
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2024 | Class I | Z-2448-2024 | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than… |
| May 7, 2024 | Class I | Z-2449-2024 | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than… |
| Mar 22, 2023 | Class I | Z-1566-2023 | Under Investigation by firm | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than… |
| Jul 2, 2014 | Class I | Z-1073-2015 | 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. |
| Jun 11, 2014 | Class II | Z-1050-2015 | Vendor change control | Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the… |
| Feb 1, 2013 | Class II | Z-0289-2014 | 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… |
| Feb 1, 2013 | Class II | Z-0290-2014 | 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-0624-2013 | 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. |
| 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-0483-2013 | 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-0209-2014 | 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-0009-2012 | 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-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-3284-2011 | 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… |
| 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. |
| Feb 14, 2011 | Not classified | Z-1644-2011 | 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. |
| Aug 11, 2009 | Not classified | Z-0027-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Aug 11, 2009 | Not classified | Z-0028-2010 | 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 19 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.
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K081412Plum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 14 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K070398Hospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K052052 (Hospira, Inc., 2005) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K031185.
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
2007high 12 (2007) · low 1 (2020)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
2007high 312 (2013) · low 66 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
2007high 102 (2009) · low 1 (2018)2026
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
2007high 888,020 (2022) · low 1,086 (2007)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?
Plum A+® and Plum A+®3 Infusion Systems with Hospira MedNetTM Software are 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/K042081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042081
Report an extraction error
Are you the manufacturer?
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