Infusomat® Space Volumetric Infusion Pump Administration Sets— 510(k) K243392

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K243392 for Infusomat® Space Volumetric Infusion Pump Administration Sets, Substantially Equivalent on 2025-07-24. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2024-10-31
Decision date: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.