BD Alaris System with Guardrails Suite MX v12.1.2— 510(k) K211218
Substantially EquivalentCarefusion 303, Inc.
FDA 510(k) clearance K211218 for BD Alaris System with Guardrails Suite MX v12.1.2, Substantially Equivalent on 2023-07-21. Applicant: Carefusion 303, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 303, Inc.
- 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 Carefusion 303, Inc.
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 K211218
K-number listed on FDA's recall record- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-1217-2026 — BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
- Z-0430-2026 — BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
- Z-2179-2025 — BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- Z-1304-2025 — BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
- Z-1305-2025 — BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
- Z-1231-2025 — BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration
- Z-3138-2024 — Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
- Z-3139-2024 — Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
- Z-3140-2024 — Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
- Z-3141-2024 — Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
- Z-3142-2024 — Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
- Z-2262-2024 — BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
- Z-0184-2024 — BD Alaris PCU REF 8015
- Z-0185-2024 — BD Alaris Syringe Module, REF 8110
- Z-0186-2024 — Alaris PCA Module 8120
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211218.
Data sourced from openFDA. This site is unofficial and independent of the FDA.