510(k) · Cleared
Recalled · Class I · 2014Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Apr 21, 2006 as substantially equivalent to K051079 (Hospicare, Inc., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2002. 7 of the 15 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 25 times, including 7 Class I recalls.
- Decided
- Apr 21, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 25 (7 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K023062 (2002). 12 later devices descend from it, 2 citing it directly. 7 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK023062 Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementAbbott Laboratories, Inc. · 2002 · Recalled
- 1 generation backK051079 Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring…Hospicare, Inc. · 2005 · Recalled
- This deviceK060806 Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6…Hospira, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
- 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 12 descendants. See all descendants
Descendants cleared per year
2008high 2 (2025) · low 0 (2009)2026
Class I recalls in this family
- K103224 Hospira Plum Infusion Set; Hospira Infusion Set…cites it directly · 2011
- K083019 Gemstar SP Infusion System with Gemstar SP…cites it directly · 2008
- 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 12 · See all- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 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 | K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management | Abbott Laboratories, Inc. | 2002 | 1 |
| −1 | K051079 | Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist… | Hospicare, Inc. | 2005 | 1 |
| 0 (this device) | K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model… | Hospira, Inc. | 2006 | — |
| +1 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2011 | 1 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051079 | Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism…Summary page 2…nformation: Devices cleared for commercial distribution and determined to be appropriate for use as predicates are summarized in the following table. KO051079 Hospira GemStar Infusion Pumlp System with Hospira 05/19/2005 GemStarSpring AssistMchanism Lo… | 2005 |
| Kept off the family tree | K041739 | FDA’s K041739 is Edwards E360 Surgical Ablation Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementSummary page 2…ssistMchanism Lockbox KHospira GemStarOR Infusion Pump System with Hospira 11/17/2004 GemStar ConnectrM Soflware K023062 Abbott GemStar® Infusion Pump System 09/30/2002 11. Comparison to Legally Marketed Device(s)… | 2002 |
What descends from it? (12)
See all 122 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 18, 2014 | Class I | Z-1512-2014 | Device Design | There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List… |
| Feb 3, 2014 | Class I | Z-0095-2015 | Process control | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply. |
| Feb 3, 2014 | Class I | Z-0096-2015 | Process control | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply. |
| Jan 31, 2014 | Class II | Z-2031-2014 | Component design/selection | The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error… |
| Mar 21, 2013 | Class II | Z-1116-2013 | Nonconforming Material/Component | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. |
| Mar 21, 2013 | Class II | Z-1117-2013 | Nonconforming Material/Component | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. |
| Mar 19, 2013 | Class II | Z-0421-2015 | Other | Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via… |
| Mar 19, 2013 | Class II | Z-0422-2015 | Other | Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via… |
| Mar 18, 2013 | Class I | Z-1159-2013 | Device Design | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. |
| Mar 18, 2013 | Class I | Z-1160-2013 | Device Design | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. |
| Mar 18, 2013 | Class I | Z-1169-2013 | Device Design | Pump shutting off during use without warning. |
| Mar 15, 2013 | Class I | Z-0349-2014 | Device Design | The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors… |
| Mar 28, 2012 | Not classified | Z-1463-2012 | Nonconforming Material/Component | Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord. |
| Aug 12, 2010 | Not classified | Z-2633-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Aug 12, 2010 | Not classified | Z-2632-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.. |
| Aug 12, 2010 | Not classified | Z-2629-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Aug 12, 2010 | Not classified | Z-2628-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Aug 12, 2010 | Not classified | Z-2630-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Aug 12, 2010 | Not classified | Z-2627-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Aug 12, 2010 | Not classified | Z-2631-2010 | Nonconforming Material/Component | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Nov 24, 2009 | Not classified | Z-1337-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1338-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1339-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Aug 11, 2009 | Not classified | Z-0014-2010 | 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-0015-2010 | 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 25 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 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 14 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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K103224 (Hospira, Inc., 2011) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K051079.
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 GemStar® Infusion Pump System is intended for use in intravenous
arterial, subcutaneous, short term epidural infusion and parenteral administration
of general I.V. fluids, medications, nutritional fluids, and blood/blood products.
The indications for use include hospital, ambulatory, and home care
environments. The pump must be used with sterile, dedicated, GemStar®
administration sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060806: Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060806
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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