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FDA 510(k)

Volumat Line

K-Number: K220301 · 2023-06-02

ApplicantFresenius Kabi
Decision Date2023-06-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Volumat Line is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K220301. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Volumat Line?

Volumat Line is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Fresenius Kabi. The 510(k) number is K220301.

When did Volumat Line receive FDA 510(k) clearance?

Volumat Line received FDA 510(k) clearance on 2023-06-02, under 510(k) number K220301.

Who is the listed applicant for Volumat Line?

The FDA 510(k) record lists Fresenius Kabi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Volumat Line?

The FDA product code for Volumat Line is FPA.

Other records listing Fresenius Kabi as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251139KabiHelp® Uno; KabiHelp® Advance plusK221121Volumat Polyethylene I.V. Administration SetK212445freeflex+ Transfer AdapterK210075Vigilant Software Suite – Vigilant Master MedK210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableK210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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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