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FDA 510(k)

BD Alaris Pump Infusion Set

K-Number: K250325 · 2025-10-30

ApplicantCarefusion (Bd)
Decision Date2025-10-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Alaris Pump Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion (Bd). It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K250325. 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 BD Alaris Pump Infusion Set?

BD Alaris Pump Infusion Set is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Carefusion (Bd). The 510(k) number is K250325.

When did BD Alaris Pump Infusion Set receive FDA 510(k) clearance?

BD Alaris Pump Infusion Set received FDA 510(k) clearance on 2025-10-30, under 510(k) number K250325.

Who is the listed applicant for BD Alaris Pump Infusion Set?

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

What is the FDA product code for BD Alaris Pump Infusion Set?

The FDA product code for BD Alaris Pump Infusion Set is FPA.

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 MedicalK251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.K251854SteadiSet infusion setTandem Diabetes Care

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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