510(k) K051641 ยท FRN Pump, Infusion
ALARIS SYSTEM PC UNIT, MODEL 8001
| Applicant | Cardinal Health, Alaris Products, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 20, 2005 |
| Received | Jun 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2026 | CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Open, Classified |
FRN | None listed |
| Nov 7, 2023 | CareFusion 303, Inc. BD Alaris PCU REF 8015 Open, Classified |
FRN | None listed |
| Nov 7, 2023 | CareFusion 303, Inc. BD Alaris Syringe Module, REF 8110 Open, Classified |
FRN | None listed |
| Nov 7, 2023 | CareFusion 303, Inc. Alaris PCA Module 8120 Open, Classified |
FRN | None listed |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris Pump Module, Model 8100 Open, Classified |
FRN | None listed |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris Syringe Module, Model 8110 Open, Classified |
FRN | None listed |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris PCA Module, Model 8120 Open, Classified |
FRN | None listed |
| Jun 19, 2017 | CareFusion 303, Inc. Alaris PC Unit, Model 8015 Terminated |
FRN | None listed |
| Nov 1, 2016 | CareFusion 303, Inc. Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. Terminated |
FRN | None listed |
| May 12, 2016 | CareFusion 303, Inc. Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19;
Central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | None listed |
| Mar 24, 2016 | CareFusion 303, Inc. Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 Terminated |
FRO | None listed |
| Mar 24, 2016 | CareFusion 303, Inc. Alaris PC unit, Model 8015
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | None listed |
| Jun 16, 2015 | CareFusion 303, Inc. Alaris PC unit model 8015, Infusion pump. software version 9.17
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software Terminated |
FRN | None listed |
| Mar 23, 2015 | CareFusion 303, Inc. Alaris PC units, Model No. 8015. Infusion pump. Terminated |
FRN | None listed |
| Dec 20, 2013 | CareFusion 303, Inc. Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600.
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply Terminated |
FRN | None listed |
| Aug 2, 2013 | CareFusion 303, Inc. Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584.
The Alaris PC Unit is the main user interface unit and power supply of the Alaris Sys Terminated |
FRN | None listed |
| Apr 15, 2013 | Carefusion Corporation Alaris PC unit model 8015 with software version 9.12
Product Usage:
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System Terminated |
FRN | None listed |
| Apr 15, 2013 | Carefusion Corporation Alaris PC unit model 8015 with software version 9.12
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | None listed |
| Jul 26, 2012 | CareFusion 303, Inc. Alaris PC unit model 8015
Product Usage: The device is labeled for prescription use only. Terminated |
FRN | None listed |
| Jan 26, 2012 | CareFusion 303, Inc. Alaris PC unit model 8015.
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | None listed |
| Oct 13, 2010 | CareFusion Corporation CareFusion Alaris PC Unit Model 8015 (formerly Medley
PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December
20, 2008 and May 6, 2009 Terminated |
FRN | None listed |
| Aug 2, 2010 | CareFusion Corporation Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module Terminated |
FRN | None listed |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above. Terminated |
FRN | None listed |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120).
The Alaris PC Unit is the central programming Terminated |
FRN | None listed |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009).
The Alaris PC Unit is the central programming and power supply component for the Alaris System modules. Terminated |
FRN | None listed |
| Aug 3, 2009 | Cardinal Health 303 dba Cardinal Health Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015;
Alaris Pump Module, Model 8100;
Alaris Patient-Controlled Analges Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.