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FDA 510(k)

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

K-Number: K210073 · 2022-03-01

ApplicantFresenius Kabi AG
Decision Date2022-03-01
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo is a medical device manufactured by Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-03-01 under approval number K210073. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo?

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Fresenius Kabi AG. The 510(k) number is K210073.

When was Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo approved by the FDA?

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo received FDA 510(k) clearance on 2022-03-01, under approval number K210073.

What company makes Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo?

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo is manufactured by Fresenius Kabi AG.

What is the FDA product code for Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo?

The FDA product code for Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo is FRN.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07578441 VitaSmart HOPE System: Bridge to HOPE Registry ENROLLING_BY_INVITATION NCT07110337 Diagnosing Epilepsy To EffeCT Change RECRUITING NCT07110454 Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up RECRUITING NCT06483750 Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction COMPLETED

Related PubMed Literature

PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Fresenius Kabi AG

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Related Devices (Code: FRN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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