ALARIS SYSTEM PC UNIT, MODEL 8001— 510(k) K051641
Substantially EquivalentCardinal Health, Alaris Products
FDA 510(k) clearance K051641 for ALARIS SYSTEM PC UNIT, MODEL 8001, Substantially Equivalent on 2005-10-20. Applicant: Cardinal Health, Alaris Products. Device class: 2.
Clearance details
- Applicant
- Cardinal Health, Alaris Products
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Cardinal Health, Alaris Products
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K051641
K-number listed on FDA's recall record- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0184-2024 — BD Alaris PCU REF 8015
- Z-0185-2024 — BD Alaris Syringe Module, REF 8110
- Z-0186-2024 — Alaris PCA Module 8120
- Z-1360-2020 — CareFusion Alaris Pump Module, Model 8100
- Z-1361-2020 — CareFusion Alaris Syringe Module, Model 8110
- Z-1362-2020 — CareFusion Alaris PCA Module, Model 8120
- Z-2671-2017 — Alaris PC Unit, Model 8015
- Z-1520-2017 — Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
- Z-2064-2016 — 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.
- Z-1606-2016 — Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
- Z-1239-2016 — Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
- Z-1811-2015 — 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 is embedded in the Alaris PC unit.
- Z-1311-2015 — Alaris PC units, Model No. 8015. Infusion pump.
- Z-0534-2014 — 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 component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
- Z-1835-2013 — 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 System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
- Z-1098-2013 — 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.
- Z-1112-2013 — 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
- Z-2076-2012 — Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051641.
Data sourced from openFDA. This site is unofficial and independent of the FDA.