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FDA 510(k)

BCM2-Body Composition Monitor

K-Number: K250634 · 2025-11-24

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2025-11-24
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BCM2-Body Composition Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K250634. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCM2-Body Composition Monitor?

BCM2-Body Composition Monitor is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250634.

When did BCM2-Body Composition Monitor receive FDA 510(k) clearance?

BCM2-Body Composition Monitor received FDA 510(k) clearance on 2025-11-24, under 510(k) number K250634.

Who is the listed applicant for BCM2-Body Composition Monitor?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BCM2-Body Composition Monitor?

The FDA product code for BCM2-Body Composition Monitor is DSB.

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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.

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