510(k) · Cleared
Recalled · Class I · 2013Gemstar SP Infusion System with Gemstar SP Infusion Suite Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Oct 22, 2008 as substantially equivalent to K060806 (Hospira, Inc., 2006) and 1 other predicate after a 13-day review. Its family tree reaches back 4 generations to 2001. 4 of the 11 devices in its family, counting itself, have a Class I recall. It has been recalled 8 times, including 4 Class I recalls.
- Decided
- Oct 22, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 8 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011442 (2001). 10 ancestors in all. No later device cites it as a predicate yet. 4 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 3 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 2 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 1 generation backK042800 Lifecare Pca Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2004 · Recalled
- This deviceK083019 Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc. · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −3 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −2 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −1 | K042800 | Lifecare Pca Infusion System with Hospira Mednet Software | Hospira, Inc. | 2004 | 5 |
| 0 (this device) | K083019 | Gemstar SP Infusion System with Gemstar SP Infusion Suite Software | Hospira, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
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.
4 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 |
|---|---|---|---|
| * | K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086…Summary page 1…SP Infusion System with Proposed Device: GemStarTM SP Infusion Suite software 5. Predicate Devices: Hospira GemStar® Infusion Pump System (K060806) LifeCare PCA ®Infusion System with Hospira MedNet TM Softwar… | 2006 |
| * | K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareSummary page 1…emStar® Infusion Pump System (K060806) LifeCare PCA ®Infusion System with Hospira MedNet TM Software (K042800) 6. Proposed Device Description: GemStarTM SP Infusion System is a family of single channel electromechanical infusi… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 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-1170-2013 | Device Design | Pump shutting off during use without warning. |
| Mar 15, 2013 | Class I | Z-0350-2014 | 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. |
| Mar 23, 2011 | Not classified | Z-1999-2011 | Software design | The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application. |
The 5 latest of 8 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.
- K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model…Hospira, Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 17 Class I recalls
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 10 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K060806.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 GemStarTM SP Infusion System with GemStar T M SP Infusion Suite software is intended for use in intravenous, arterial, subcutaneous, shod 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/K083019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083019: Gemstar SP Infusion System with Gemstar SP Infusion Suite Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083019
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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