K250634 is an FDA 510(k) clearance for the BCM2-Body Composition Monitor. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on November 24, 2025, 266 days after receiving the submission on March 3, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K250634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2025 |
| Decision Date | November 24, 2025 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | DSB — Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |