510(k) · Cleared
Recalled · Class I · 2026Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Jan 16, 2015 as substantially equivalent to K042081 (Hospira, Inc., 2004) and 7 other predicates after a 198-day review. Its family tree reaches back 5 generations to 2001. 11 of the 34 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 11 times, including 2 Class I recalls.
- Decided
- Jan 16, 2015
- Review
- 198 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 11 (2 Class I)
- Predicates
- 8
Its longest line of descent runs back 5 generations to K011442 (2001). 24 ancestors in all, the oldest K780880 (1978). 9 later devices descend from it, 2 citing it directly. 11 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 4 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 3 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 2 generations backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- 1 generation backK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- This deviceK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK223607 Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK183311 Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK253558 Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
2016high 2 (2025) · low 0 (2018)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · cites it directly5descendants
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 2 generations on2descendants
- K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien · 2016 · cites it directly2descendants
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 2 generations on1descendant
- K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −4 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −3 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −2 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| −1 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| 0 (this device) | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | — |
| +1 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| +2 | K223607 | Plum Duo™ Infusion System | Icu Medical, Inc. | 2023 | Class I |
| +1 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets… | Covidien | 2016 | 5 |
| +2 | K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | 2019 | Class I |
| +2 | K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026 | — |
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 |
|---|---|---|
| 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.
11 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? (8)
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 4…FRN, PHC, FPA Legally Marketed Device(s) To Which Infusion System: Equivalence is Claimed Plum A+™ Infusion System with Hospira Mednet™ (K042081) Administration Sets: Abbott Plum A+ Pump… | 2004 |
| * | K982159 | Abbott Plum a+ Infusion PumpSummary page 4…with Hospira Mednet™ (K042081) Administration Sets: Abbott Plum A+ Pump and Sets (K982159) Lifeshield Latex-Free Microbore Extentsion Set, Model 14949 and… | 1999 |
| * | K052722 | Lifeshield Latex-Free Microbore Extension Set, Model 14949 and OthersSummary page 4…(K982159) Lifeshield Latex-Free Microbore Extentsion Set, Model 14949 and Others (K052722) Hospira Enteral Feeding Set, Model 20640 (K061432)… | 2005 |
| * | K061432 | Hospira Enteral Feeding Set, Model 20640Summary page 4…n Set, Model 14949 and Others (K052722) Hospira Enteral Feeding Set, Model 20640 (K061432) Hospira Infusion Blood Sets (K101677) Ho… | 2006 |
| * | K101677 | Hospira Infusion Blood SetsSummary page 4…) Hospira Enteral Feeding Set, Model 20640 (K061432) Hospira Infusion Blood Sets (K101677) Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe… | 2010 |
| * | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingSummary page 4…01677) Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing (K103224) Plum 360™ Infusion system with Hospira MedNet™/ Smart Card Plug ‘n’ Play CE 3.0 Module Traditional 510(k) Sectio… | 2011 |
| * | K103344 | Infusion SetsSummary page 5…spira MedNet™/ Smart Card Plug ‘n’ Play CE 3.0 Module Traditional 510(k) Section 5: 510(k) Summary Infusion Sets (K103344) Lifeshield Vision Infusion Set with Pre-pierced Reseal (K113683) Reason f… | 2010 |
| * | K113683 | Lifeshield Vision Infusion Set with Pre-Pierced ResealSummary page 5…Infusion Sets (K103344) Lifeshield Vision Infusion Set with Pre-pierced Reseal (K113683) Reason for 510(k) Submission Introduction of the next generation of Plum™ Infusion System-Plum… | 2012 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-3162-2026 | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration… |
| May 7, 2024 | Class I | Z-2447-2024 | 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… |
| Jul 13, 2023 | Class II | Z-2430-2023 | Nonconforming Material/Component | Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. |
| Mar 22, 2023 | Class I | Z-1565-2023 | 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 29, 2019 | Class II | Z-0127-2020 | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| Jul 29, 2019 | Class II | Z-0128-2020 | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| Jul 29, 2019 | Class II | Z-0145-2020 | Under Investigation by firm | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| Jun 15, 2017 | Class II | Z-3031-2017 | Under Investigation by firm | Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion. |
| Dec 30, 2016 | Class II | Z-1682-2017 | Software in the Use Environment | Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power… |
| Mar 25, 2016 | Class II | Z-1832-2016 | Process control | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal… |
| Mar 25, 2016 | Class II | Z-1833-2016 | Process control | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal… |
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.
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · Direct predicate · ◆ 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 · Direct predicate · ◆ 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 · 2 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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 12 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 18 of the 24 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K161469 (Hospira, Inc., 2017) has gone furthest, with 5 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. 2015, this device’s year, is highlighted.
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 360™ Infusion System with Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion System 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/K141789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141789
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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