Cleared Traditional

Infusomat? Space Volumetric Infusion Pump Administration Sets

K243392 · B.Braun Medical, Inc. · General Hospital
Jul 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K243392 is an FDA 510(k) clearance for the Infusomat? Space Volumetric Infusion Pump Administration Sets, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 24, 2025, 266 days after receiving the submission on October 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K243392 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date July 24, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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