510(k) · Cleared
Recalled · Class I · 2026Alaris System PC Unit, Model 8001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · FRN Pump, Infusion
Cleared on Oct 20, 2005 as substantially equivalent to K950419 (Imed Corp., 1995) after a 122-day review. Its family tree reaches back 1 generation to 1995. 4 of the 8 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 26 times, including 10 Class I recalls.
- Decided
- Oct 20, 2005
- Review
- 122 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 26 (10 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950419 (1995). 6 later devices descend from it, 2 citing it directly. 4 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK950419 The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Recalled (Class I)
- This deviceK051641 Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005
- Descendant · cites it directly · 5 of its ownK091308 Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 2009
- Descendant · cites it directly · 3 of its ownK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 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)
- Descendant · 3 generations on · 0 of its ownK243855 BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia…Fresenius Kabi AG · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K091308Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 2009 · cites it directly5descendants
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · cites it directly3descendants
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 2 generations on1descendant
- K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025 · 3 generations on0descendants
- K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950419 | The Imed Orion Infusion Pump and Administration Sets | Imed Corp. | 1995 | Class I |
| 0 (this device) | K051641 | Alaris System PC Unit, Model 8001 | Cardinal Health, Alaris Products | 2005 | — |
| +1 | K091308 | Alaris PC Unit, Models 8000 and 8015 | Cardinal Health 303,Inc. | 2009 | — |
| +1 | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | Class I |
| +2 | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023 | Class I |
| +3 | K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025 | — |
| +2 | K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link… | Fresenius Kabi AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K950419 | The Imed Orion Infusion Pump and Administration SetsSummary page 2…Predicate Device Manufacturer 510(k No. Date Cleared Alaris System Cardinal Health, Alaris K950419 June 21, 1995 (originally submitted as Products IMED Orion Infusion System)_ INTEN… | 1995 |
What descends from it? (6)
2 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 11, 2026 | Class II | Z-1645-2026 | Under Investigation by firm | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units |
| Sep 15, 2023 | Class I | Z-0185-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Sep 15, 2023 | Class I | Z-0184-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Sep 15, 2023 | Class I | Z-0186-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| 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, 2017 | Class II | Z-2671-2017 | Software design | BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions. |
| Nov 1, 2016 | Class II | Z-1520-2017 | Use error | Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. |
| May 12, 2016 | Class II | Z-2064-2016 | Software design | A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. |
| Mar 24, 2016 | Class II | Z-1606-2016 | Nonconforming Material/Component | The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards. |
| Feb 12, 2016 | Class II | Z-1239-2016 | Under Investigation by firm | CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630). |
| May 13, 2015 | Class II | Z-1811-2015 | Software design | An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication. |
| Mar 12, 2015 | Class II | Z-1311-2015 | Process control | CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue. |
| Dec 5, 2013 | Class I | Z-0534-2014 | Software design | CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message. |
| Jun 17, 2013 | Class I | Z-1835-2013 | Process design | CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard… |
| Mar 6, 2013 | Class II | Z-1112-2013 | Software design | The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic… |
| Mar 6, 2013 | Class I | Z-1098-2013 | Software design | The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. |
| May 25, 2012 | Class I | Z-2076-2012 | Component design/selection | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied… |
| Sep 13, 2011 | Not classified | Z-0876-2012 | Nonconforming Material/Component | The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a… |
| Aug 2, 2010 | Not classified | Z-0492-2011 | Device Design | Than recall was initiated because CareFusion has identified identified a potential risk associated with the Alaris PC unit formerly known as Medley PC unit (PC Unit) model 8000 only when used with Alaris Pump module (Pump module) or… |
| Jul 13, 2010 | Not classified | Z-0006-2011 | Component design/selection | Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this… |
| 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… |
| Jun 12, 2009 | Not classified | Z-1792-2009 | Device Design | There is a potential in the specified ESD (electrostatic discharge) protection circuitry in the keypad of Alaris PC units manufactured or serviced between April 2008 through January 2009. In these units there is a potential for the keypad… |
The 5 latest of 26 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.
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- 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?
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 Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris System module is specified in its respective submission.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051641: Alaris System PC Unit, Model 8001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051641
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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