510(k) · Cleared
Recalled · 2012Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospicare, Inc. · MRZ Accessories, Pump, Infusion
Cleared on May 19, 2005 as substantially equivalent to K023062 (Abbott Laboratories, Inc., 2002) after a 22-day review. Its family tree reaches back 1 generation to 2002. 7 of the 32 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled once.
- Decided
- May 19, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023062 (2002). 30 later devices descend from it, 2 citing it directly. 7 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK023062 Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementAbbott Laboratories, Inc. · 2002 · Recalled
- This deviceK051079 Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring…Hospicare, Inc. · 2005
- Descendant · cites it directly · 16 of its ownK061110 Glucommander PlusCollaborativemed, LLC · 2006
- Descendant · 2 generations on · 13 of its ownK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- Descendant · 3 generations on · 12 of its ownK113853 G+ SystemGlytec, LLC · 2012
- Descendant · cites it directly · 12 of its ownK060806 Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6…Hospira, Inc. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060806 Hospira Gemstar Infusion Pump System, 7 Therapy…cites it directly · 2006
- K103224 Hospira Plum Infusion Set; Hospira Infusion Set…2 generations on · 2011
- K083019 Gemstar SP Infusion System with Gemstar SP…2 generations on · 2008
- K141789 Plum 360 Infusion System with Hospira Mednet…3 generations on · 2015
Most influential descendants
Showing 5 of 30 · See all- K061110Glucommander PlusCollaborativemed, LLC · 2006 · cites it directly16descendants
- K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010 · 2 generations on13descendants
- K113853G+ SystemGlytec, LLC · 2012 · 3 generations on12descendants
- K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086…Hospira, Inc. · 2006 · cites it directly12descendants
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management | Abbott Laboratories, Inc. | 2002 | 1 |
| 0 (this device) | K051079 | Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist… | Hospicare, Inc. | 2005 | — |
| +1 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| +2 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| +3 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| +1 | K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model… | Hospira, Inc. | 2006 | Class I |
| +2 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 1 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 3 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementSummary page 3…ump System with Hospira K8 11/17/2004 GemStar ConnectTM Software K023062 Abbott GemStar ® Infusion Pump System 09/30/2002 Lifeshield Primary IV Pump Set w… | 2002 |
| * | — | Hospira GemStar® Infusion Pump System with Hospira GemStar Connect™ Software Named without a submission number | |
| * | — | Lifeshield Primary IV Pump Set with Two Pressure Activated Anti-Siphon Valves Named without a submission number |
What descends from it? (30)
See all 302 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 |
|---|---|---|---|---|
| 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. |
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 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 17 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc. · 2008 · 2 generations on · ◆ 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 · 3 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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/K051079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051079: Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051079
Report an extraction error
Are you the manufacturer?
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