510(k) Report

510(k) · Cleared

Recalled · 2012

Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software

K042980510(k) SpecialCleared Nov 17, 200419-day reviewClass II21 CFR 880.5725Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hospira, Inc. · FRN Pump, Infusion

Cleared on Nov 17, 2004 as substantially equivalent to K023062 (Abbott Laboratories, Inc., 2002) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 2 times.

Decided
Nov 17, 2004
Review
19 days
Class
Class II
Product code
FRN
Recalls
2
Predicates
2

Its longest line of descent runs back 1 generation to K000821 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK000821 · Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1 Therapy Configuration · Abbott Laboratories · 20002000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K000821 · Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1 Therapy Configuration · Abbott Laboratories · 20000
  1. Root · 1 generation backK000821 Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6…Abbott Laboratories · 2000
  2. This deviceK042980 Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect SoftwareHospira, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000821Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy…Abbott Laboratories2000—
0 (this device)K042980Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect SoftwareHospira, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K042980, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in FRN? 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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K023062Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management
Summary page 2
…on: Infusion pumps cleared for commercial distribution and determined to be appropriate for use as predicates are sunmmnarized in the following table. [K023062'~ ~ Abbott GemSta? Infusion PumpSytm03022 IK000821 [Gemt ~.V..rV. Infusion Pump…
Abbott Laboratories, Inc.20021
*K000821Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1…
Summary page 2
…ned to be appropriate for use as predicates are sunmmnarized in the following table. [K023062'~ ~ Abbott GemSta? Infusion PumpSytm03022 IK000821 [Gemt ~.V..rV. Infusion Pump [05/24/200 11. Statement of Substantial Equivalence: The H…
Abbott Laboratories2000—

Also cleared against K023062: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 28, 2012Not classifiedZ-1463-2012Nonconforming Material/ComponentHospira 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 1, 2011Not classifiedZ-3107-2011Device DesignHospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K023062.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
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

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect" Software 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.

Also cleared against K023062

3 other devices cite the same predicate.

  • K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model…Hospira, Inc. · 20067 Class I recalls
  • K051079Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 TherapyHospicare, Inc. · 20051 recall
  • K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 20042 Class I recalls

More from Hospira, Inc.

52 FDA decisions under this applicant name. See the company

  • K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 20172 Class I recalls
  • K161036Hospira Extension Set, Hospira Primary SetHospira, Inc. · 2017
  • K160492Hospira Sapphire SetsHospira, Inc. · 2016
  • K160870Hospira Administration SetsHospira, Inc. · 2016
  • K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K042980 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042980: Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042980

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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