# K110901: Symbiq Infusion and Adminstration Set

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Mar 5, 2012 after 340 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 13 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011442 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041550: Hospira Phoenix Infusion System with Hospira Mednet Software, Abbott Laboratories (2004) Summary page 1.

## Most influential descendants
- K121032: Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp (2012), 0 descendants of its own

## Recalls of this device
- Dec 22, 2015 · Class II · Z-0863-2016: Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
- Aug 28, 2013 · Class II · Z-0372-2014: 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: 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)
- Feb 5, 2013 · Class II · Z-0354-2017: 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)
- Feb 4, 2013 · Class II · Z-0306-2017: 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
- Feb 4, 2013 · Class II · Z-0305-2017: 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
- Feb 4, 2013 · Class II · Z-2056-2016: 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 
- Feb 4, 2013 · Class II · Z-1847-2013: The devices secondary audio signal fails to activate.
- Feb 4, 2013 · Class II · Z-2055-2016: 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 
- Aug 29, 2012 · Class I · Z-0069-2013: 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 r
- Aug 29, 2012 · Class I · Z-0070-2013: 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 r
- Mar 16, 2011 · Class II · Z-0362-2017: 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
- Mar 16, 2011 · Class II · Z-0361-2017: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K110901
Methodology: https://510kreport.com/methodology