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FDA 510(k)

Infusomat® Space Volumetric Infusion Pump Administration Sets

K-Number: K243392 · 2025-07-24

ApplicantB.Braun Medical, Inc.
Decision Date2025-07-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infusomat® Space Volumetric Infusion Pump Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K243392. 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 Infusomat® Space Volumetric Infusion Pump Administration Sets?

Infusomat® Space Volumetric Infusion Pump Administration Sets is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K243392.

When did Infusomat® Space Volumetric Infusion Pump Administration Sets receive FDA 510(k) clearance?

Infusomat® Space Volumetric Infusion Pump Administration Sets received FDA 510(k) clearance on 2025-07-24, under 510(k) number K243392.

Who is the listed applicant for Infusomat® Space Volumetric Infusion Pump Administration Sets?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infusomat® Space Volumetric Infusion Pump Administration Sets?

The FDA product code for Infusomat® Space Volumetric Infusion Pump Administration Sets is FPA.

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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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