510(k) · Cleared
ClearedBCM2-Body Composition Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · DSB Plethysmograph, Impedance
Cleared on Nov 24, 2025 as substantially equivalent to K142503 (Intersection Medical, Inc., 2015) and 1 other predicate after a 266-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Nov 24, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922218 (1992). 8 ancestors in all, the oldest K904109 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 5 generations backK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- 4 generations backK112830 Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc. · 2012
- 3 generations backK131509 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013
- 2 generations backK133301 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014
- 1 generation backK142503 Imed-Z Fluid Status MonitorIntersection Medical, Inc. · 2015
- This deviceK250634 BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| −5 | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| −4 | K112830 | Zoefluid Status Monitor (Model Zoe 2B) | Noninvasive Medical Technologies, Inc. | 2012 | — |
| −3 | K131509 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2013 | — |
| −2 | K133301 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2014 | — |
| −1 | K142503 | Imed-Z Fluid Status Monitor | Intersection Medical, Inc. | 2015 | — |
| 0 (this device) | K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142503 | Imed-Z Fluid Status MonitorSummary page 5…raph, Impedance FDA Review Panel: Cardiovascular 1.3. Legally Marketed Predicate Device 1.3.1. Predicate Device – Intersection Medical Inc. IMED-Z (K142503) The predicate device for the BCM2 - Body Composition Monitor (hereinafter referred to as the “BCM2”) is the IMED-Z Fluid Status… | 2015 |
| * | K904109 | Bio-Impedance AnalyzerSummary page 5…Fluid Status Monitor (K142503). The IMED-Z has not been the subject of a design-related recall. 1.3.2. Reference Device – Xitron Hydra 4000 The Xitron Hydra 4000 (K904109) is being used as a reference device to demonstrate the equivalence of technological characteristics (i.e., bioimpedance spectros… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 8.2 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K142503.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BCM2 is intended for use, under the direction of a physician, for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease (ESKD) including those receiving maintenance dialysis.
The device does not generate any real-time alarms and outputs from the device should be used in the context of all clinical data to assess a patient's fluid status.
The device is intended for use in patients 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250634: BCM2-Body Composition Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250634
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026