Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2025-07-24 under approval 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. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K243392.

When was Infusomat® Space Volumetric Infusion Pump Administration Sets approved by the FDA?

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

What company makes Infusomat® Space Volumetric Infusion Pump Administration Sets?

Infusomat® Space Volumetric Infusion Pump Administration Sets is manufactured by B.Braun Medical, Inc..

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.

Related Clinical Trials

NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT04542148 Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes ACTIVE_NOT_RECRUITING NCT06729827 Predictive Hemodynamic Monitoring During Elective Cesarean Section COMPLETED NCT06710223 Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by B.Braun Medical, Inc.

K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL K153297Perifix and Contiplex Catheter K153293Extension Set K151423APEX Compounding System Transfer Set K151772Actreen Mini Intermittent Urinary Catheters K171584B. Braun Tear-Away Introducer Needle

View all 34 devices →

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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.

↑