ClearanceBrief
510(k) K211218 ยท FRN Pump, Infusion

BD Alaris System with Guardrails Suite MX v12.1.2

ApplicantCarefusion 303, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Jul 21, 2023
ReceivedApr 23, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K211218

DateFirm and productCodeLinked 510(k)
Mar 26, 2026CareFusion 303, Inc.
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Open, Classified		 FRNNone listed
Jan 29, 2026CareFusion 303, Inc.
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 admi
Open, Classified		 FRNNone listed
Nov 20, 2025CareFusion 303, Inc.
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 Infu
Open, Classified		 FRNNone listed
Aug 6, 2025CareFusion 303, Inc.
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Open, Classified		 FRNNone listed
Mar 13, 2025CareFusion 303, Inc.
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Open, Classified		 PHCNone listed
Mar 13, 2025CareFusion 303, Inc.
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Open, Classified		 PHCNone listed
Feb 24, 2025CareFusion 303, Inc.
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, ped
Open, Classified		 FRNNone listed
Sep 13, 2024CareFusion 303, Inc.
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Open, Classified		 FRNNone listed
Sep 13, 2024CareFusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Open, Classified		 FRNNone listed
Sep 13, 2024CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Open, Classified		 FRNNone listed
Sep 13, 2024CareFusion 303, Inc.
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Open, Classified		 FRNNone listed
Sep 13, 2024CareFusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Open, Classified		 FRNNone listed
Jul 3, 2024CareFusion 303, Inc.
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Open, Classified		 FRNNone listed
Nov 7, 2023CareFusion 303, Inc.
BD Alaris PCU REF 8015
Open, Classified		 FRNNone listed
Nov 7, 2023CareFusion 303, Inc.
BD Alaris Syringe Module, REF 8110
Open, Classified		 FRNNone listed
Nov 7, 2023CareFusion 303, Inc.
Alaris PCA Module 8120
Open, Classified		 FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.