510(k) · Cleared
ClearedAlaris PC Unit, Models 8000 and 8015
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 303,Inc. · FRN Pump, Infusion
Cleared on Jul 9, 2009 as substantially equivalent to K051641 (Cardinal Health, Alaris Products, 2005) after a 66-day review. Its family tree reaches back 2 generations to 1995. 4 of the 8 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jul 9, 2009
- Review
- 66 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950419 (1995). 5 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 · 2 generations backK950419 The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Recalled (Class I)
- 1 generation backK051641 Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · Recalled (Class I)
- This deviceK091308 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
- Descendant · cites it directly · 0 of its ownK110535 Alaris PC Unit Module 8000 with Software CorrectionCarefusion 303, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- 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
- K110535Alaris PC Unit Module 8000 with Software CorrectionCarefusion 303, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950419 | The Imed Orion Infusion Pump and Administration Sets | Imed Corp. | 1995 | Class I |
| −1 | K051641 | Alaris System PC Unit, Model 8001 | Cardinal Health, Alaris Products | 2005 | Class I |
| 0 (this device) | 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 | — |
| +1 | K110535 | Alaris PC Unit Module 8000 with Software Correction | Carefusion 303, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051641 | Alaris System PC Unit, Model 8001 | 2005 |
What descends from it? (5)
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)
No FDA recall names this device.
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.
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · Direct predicate · ◆ on the line of descent in FIG. 110 Class I recalls
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K133532 (Carefusion 303, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K051641.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 TM 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/K091308 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091308: Alaris PC Unit, Models 8000 and 8015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091308
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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