510(k) · Cleared
Recalled · 2012Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories, Inc. · FRN Pump, Infusion
Cleared on Sep 30, 2002 after a 14-day review. The FDA summary names its predicate without a number. 9 of the 37 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it. It has been recalled once.
- Decided
- Sep 30, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 0
36 later devices descend from it, 4 citing it directly. 9 of the 37 devices in this family, counting this one, have a Class I recall.
- This deviceK023062 Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementAbbott Laboratories, Inc. · 2002
- Descendant · cites it directly · 30 of its ownK051079 Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring…Hospicare, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 16 of its ownK061110 Glucommander PlusCollaborativemed, LLC · 2006
- Descendant · 3 generations on · 13 of its ownK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- Descendant · cites it directly · 13 of its ownK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Recalled (Class I)
- Descendant · 4 generations on · 12 of its ownK113853 G+ SystemGlytec, LLC · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K041550 Hospira Phoenix Infusion System with Hospira…cites it directly · 2004
- K060806 Hospira Gemstar Infusion Pump System, 7 Therapy…cites it directly · 2006
- K110901 Symbiq Infusion and Adminstration Set2 generations on · 2012
- K103224 Hospira Plum Infusion Set; Hospira Infusion Set…2 generations on · 2011
Most influential descendants
Showing 5 of 36 · See all- K051079Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism…Hospicare, Inc. · 2005 · cites it directly30descendants
- K061110Glucommander PlusCollaborativemed, LLC · 2006 · 2 generations on16descendants
- K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010 · 3 generations on13descendants
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · cites it directly13descendants
- K113853G+ SystemGlytec, LLC · 2012 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management | Abbott Laboratories, Inc. | 2002 | — |
| +1 | K051079 | Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist… | Hospicare, Inc. | 2005 | 1 |
| +2 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| +3 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| +1 | K041550 | Hospira Phoenix Infusion System with Hospira Mednet Software | Abbott Laboratories | 2004 | Class I |
| +4 | K113853 | G+ System | Glytec, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 1 |
| 2005 | 1 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2010 | 2 | 0 |
| 2011 | 1 | 1 |
| 2012 | 3 | 1 |
| 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.
9 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 |
|---|---|---|---|
| * | — | Abbott GemStarTM I.V. Infusion Pump Named without a submission number |
What descends from it? (36)
See all 364 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051079 | Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism… | 2005 | 30 |
| K041550 | Hospira Phoenix Infusion System with Hospira Mednet Software Class I | 2004 | 13 |
| K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086… Class I | 2006 | 12 |
| K042980 | Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software | 2004 | 0 |
Has anything in its family been recalled? (9 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.
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 12 Class I recalls
- 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
- K110901Symbiq Infusion and Adminstration SetHospira, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 12 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 9; all are on the web page.
What does this lineage say?
- Of its descendants, K051079 (Hospicare, Inc., 2005) has gone furthest, with 30 descendants of its own.
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
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 Abbott Gemstar@Infusion Pump System has the following indications for use:
The Abbott Gemstar@Infusion Pump is intended for use in intravenous arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023062 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023062: Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023062
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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