510(k) · Cleared
Recalled · Class I · 2013Hospira Phoenix Infusion System with Hospira Mednet Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FRN Pump, Infusion
Cleared on Jun 30, 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. 7 of the 18 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 36 times, including 2 Class I recalls.
- Decided
- Jun 30, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 36 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011442 (2001). 4 ancestors in all. 13 later devices descend from it, 2 citing it directly. 7 of the 18 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 deviceK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004
- Descendant · cites it directly · 10 of its ownK103344 Infusion SetsHospira, Inc. · 2010
- 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 13 descendants. See all descendants
Descendants cleared per year
2010high 2 (2012) · low 0 (2011)2026
Class I recalls in this family
- K011442 Abbott Plum a+Infusion Pump, Model 119712 generations back · 2001
- K110901 Symbiq Infusion and Adminstration Setcites it directly · 2012
- K141789 Plum 360 Infusion System with Hospira Mednet…2 generations on · 2015
- K161469 Plum 360(TM) Infusion System with MedNet/ Smart…3 generations on · 2017
Most influential descendants
Showing 5 of 13 · See all- K103344Infusion SetsHospira, Inc. · 2010 · 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 |
|---|---|---|---|---|---|
| −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) | K041550 | Hospira Phoenix Infusion System with Hospira Mednet Software | Abbott Laboratories | 2004 | — |
| +1 | K103344 | Infusion Sets | Hospira, Inc. | 2010 | — |
| +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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 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.
7 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…evice: Software 5. Predicate Devices: Abbott Plum A+® Infusion Pump with HPLJRS with the plug-and-play Module (K031 185) Abbott GemstarTm l.V. Infusion Pump system (K(023062) 6. Proposed Device Description:… | 2003 |
| * | K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementSummary page 1…with HPLJRS with the plug-and-play Module (K031 185) Abbott GemstarTm l.V. Infusion Pump system (K(023062) 6. Proposed Device Description: The Abbott Phoenix Infusion System with Abbott MedNetwM Software is comprised of… | 2002 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2013 | Class II | Z-2056-2016 | Software design | Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a… |
| Feb 4, 2013 | Class II | Z-2055-2016 | Software design | Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a… |
| Aug 29, 2012 | Class I | Z-0069-2013 | Device Design | The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a… |
| Aug 29, 2012 | Class I | Z-0070-2013 | Device Design | The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a… |
| Mar 16, 2011 | Class II | Z-0362-2017 | Device Design | May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute… |
| Mar 16, 2011 | Class II | Z-0361-2017 | Device Design | May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute… |
| Apr 9, 2010 | Not classified | Z-1895-2010 | Device Design | Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation. |
| Apr 9, 2010 | Not classified | Z-1894-2010 | Device Design | Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation. |
| Mar 26, 2010 | Not classified | Z-2381-2010 | Device Design | If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result. |
| Feb 22, 2010 | Not classified | Z-0127-2011 | Device Design | Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy. |
| Feb 22, 2010 | Not classified | Z-0128-2011 | Device Design | Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy. |
| Feb 22, 2010 | Not classified | Z-2391-2010 | Device Design | The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container. |
| Feb 22, 2010 | Not classified | Z-2390-2010 | Device Design | The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container. |
| Jan 8, 2010 | Not classified | Z-0808-2010 | Process control | There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure. |
| Nov 24, 2009 | Not classified | Z-1053-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1045-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1050-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1052-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1055-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1056-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1058-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1061-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1062-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1063-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1046-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1047-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1048-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1049-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1051-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1054-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1057-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1059-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Nov 24, 2009 | Not classified | Z-1060-2010 | Process control | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
| Mar 31, 2009 | Not classified | Z-1816-2009 | Software design | Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage. |
| Mar 31, 2009 | Not classified | Z-1815-2009 | Software design | Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage. |
| Dec 3, 2008 | Not classified | Z-0944-2009 | Software design | Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations. |
The 5 latest of 36 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
- K110901Symbiq Infusion and Adminstration SetHospira, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of 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 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 6; all are on the web page.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; 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, K103344 (Hospira, Inc., 2010) has gone furthest, with 10 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?
The Hospira Phoenix Infusion System with Hospira MedNet Software is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041550: Hospira Phoenix 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/K041550
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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