510(k) · Cleared
Recalled · Class I · 2015Symbiq Infusion and Adminstration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Mar 5, 2012 as substantially equivalent to K041550 (Abbott Laboratories, 2004) after a 340-day review. Its family tree reaches back 3 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 13 times, including 2 Class I recalls.
- Decided
- Mar 5, 2012
- Review
- 340 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 13 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011442 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 7 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 backK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Recalled (Class I)
- This deviceK110901 Symbiq Infusion and Adminstration SetHospira, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK121032 Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter…Hospira, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K121032Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-DehpHospira, Inc. · 2012 · cites it directly0descendants
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 | K041550 | Hospira Phoenix Infusion System with Hospira Mednet Software | Abbott Laboratories | 2004 | Class I |
| 0 (this device) | K110901 | Symbiq Infusion and Adminstration Set | Hospira, Inc. | 2012 | — |
| +1 | K121032 | Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp | Hospira, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 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.
3 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 |
|---|---|---|---|
| * | K041550 | Hospira Phoenix Infusion System with Hospira Mednet SoftwareSummary page 1…FRN and FPA Legally marketed device(s) Hospira Phoenix Infusion System with Hospira MedNet to which equivalence is Software, cleared under K041550 on 06/30/2004 claimed Reason for 510(k) Cumulative changes submission Device description Symbiql T… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121032 | Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp | 2012 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2015 | Class II | Z-0863-2016 | Nonconforming Material/Component | Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. |
| Aug 28, 2013 | Class II | Z-0372-2014 | Employee error | Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers. |
| Feb 5, 2013 | Class II | Z-0353-2017 | Process control | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September… |
| Feb 5, 2013 | Class II | Z-0354-2017 | Process control | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September… |
| Feb 4, 2013 | Class II | Z-0306-2017 | Software design | Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a… |
| Feb 4, 2013 | Class II | Z-0305-2017 | Software design | Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a… |
| 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-1847-2013 | Process control | The devices secondary audio signal fails to activate. |
| 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… |
The 5 latest of 13 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.
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Direct predicate · ◆ on the line of descent in 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
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K121032 (Hospira, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041550.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 SymbiqTM Infusion System 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 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/K110901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110901: Symbiq Infusion and Adminstration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110901
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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