K243392 is an FDA 510(k) clearance for the Infusomat® Space Volumetric Infusion Pump Administration Sets. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K243392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |