BCM2-Body Composition Monitor
FDA 510(k) K250634 · Fresenius Medical Care Renal Therapies Group, LLC
510(k) numberK250634
Submission
- Device name
- BCM2-Body Composition Monitor
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
Waltham, MA, US - Received
- March 3, 2025
- Decision date
- November 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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Questions and answers
When was BCM2-Body Composition Monitor cleared by the FDA?
BCM2-Body Composition Monitor (K250634) received a 510(k) decision of Substantially Equivalent on November 24, 2025, 266 days after the submission was received.
What is the product code of K250634?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.