510(k) · Cleared
Recalled · Class I · 2020Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alaris Medical Systems, Inc. · FRN Pump, Infusion
Cleared on Oct 2, 2001 as substantially equivalent to K010924 (Abbott Laboratories, 2001) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 2000. 4 of the 16 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 12 times, including 3 Class I recalls.
- Decided
- Oct 2, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 12 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002211 (2000). 2 ancestors in all. 13 later devices descend from it, 4 citing it directly. 4 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
- This deviceK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · Recalled
- Descendant · cites it directly · 3 of its ownK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK030136 Drip AlertDrip Alert, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK090087 Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK211218 BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K050301Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · cites it directly4descendants
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · cites it directly3descendants
- K030136Drip AlertDrip Alert, Inc. · 2003 · cites it directly3descendants
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · cites it directly2descendants
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | 4 |
| 0 (this device) | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | — |
| +1 | K050301 | Mridium 3850 Mri Pump System | Iradimed Corporation | 2005 | 2 |
| +1 | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | Class I |
| +1 | K030136 | Drip Alert | Drip Alert, Inc. | 2003 | — |
| +1 | K090087 | Mridium 3860 Mri Infusion Pump/Monitoring System | Iradimed Corporation | 2009 | Class I |
| +2 | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 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.
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 |
|---|---|---|---|
| * | K010924 | Modification to Plum XL Infusion PumpSummary page 2…AND EFFECTIVENESS, Continued ALARIS Medical Systems, Inc. Page 2 of 3 Predicate Device(s) ‘Manufacturer and Device S10(k)# | Date Cleared Abbott Plum XL Infusion Pump K010924 04/06/01 Colleague Volumetric and CX Volumetric Infusion K002211 08/28/00 Pumps ’ DEVICE DESCRIPTION ALARIS Medical Systems line… | 2001 |
| * | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151Summary page 2…of 3 Predicate Device(s) ‘Manufacturer and Device S10(k)# | Date Cleared Abbott Plum XL Infusion Pump K010924 04/06/01 Colleague Volumetric and CX Volumetric Infusion K002211 08/28/00 Pumps ’ DEVICE DESCRIPTION ALARIS Medical Systems line of infusion pumps are electrical volumetric infusion pumps that… | 2000 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2020 | Class I | Z-1360-2020 | Device Design | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion… |
| Feb 4, 2020 | Class I | Z-1362-2020 | Device Design | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion… |
| Feb 4, 2020 | Class I | Z-1361-2020 | Device Design | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion… |
| Jun 12, 2009 | Not classified | Z-1790-2009 | Device Design | There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail… |
| Jun 12, 2009 | Not classified | Z-1791-2009 | Device Design | Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of… |
| Jun 12, 2009 | Not classified | Z-1794-2009 | Device Design | There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become… |
| Mar 4, 2009 | Not classified | Z-1237-2009 | Software design | The Alaris PCA module can potentially infuse above or below the intended infusion dose. |
| Mar 5, 2008 | Not classified | Z-1712-2008 | Device Design | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the… |
| Mar 5, 2008 | Not classified | Z-1710-2008 | Device Design | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the… |
| Mar 5, 2008 | Not classified | Z-1711-2008 | Device Design | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System… |
| Aug 10, 2006 | Not classified | Z-1484-06 | Software design | This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce. |
| Nov 10, 2004 | Not classified | Z-0568-05 | Other | The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have… |
The 5 latest of 12 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.
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K050301 (Iradimed Corporation, 2005) has gone furthest, with 4 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?
ALARIS Medical Systems infusion pumps are intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products. The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous…
Read the full statement (136 words)
ALARIS Medical Systems infusion pumps are intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.
The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces:
IMED® Gemini Infusion Pump / Controllers model PC-1®
IMED® Gemini Infusion Pump / Controllers model PC-2®
IMED® Gemini Infusion Pump/Controller model PC-2TX®
IMED® Gemini Infusion Pump/Controller model PC-4*
IVAC® Signature Edition® Infusion Pumps
IVAC® MedSystem III®, Multi-channel Infusion Pumps
IVAC® MedSystem I1I® Multi-channel Infusion Pumps with DLE
ALARIS Medical Medley™ Patient Care System
Note: See the appropriate Directions for Use (DFU) for infusion system specifications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012383
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026