510(k) · Cleared
ClearedRe:Balans
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mode Sensors AS · DSB Plethysmograph, Impedance
Cleared on Oct 16, 2025 as substantially equivalent to K142503 (Intersection Medical, Inc., 2015) after a 317-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Oct 16, 2025
- Review
- 317 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922218 (1992). 7 ancestors in all. 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 deviceK243727 Re:BalansMode Sensors AS · 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) | K243727 | Re:Balans | Mode Sensors AS | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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…ss Class II Product Code: DSB Classification Regulation: 870.2770 Predicate Device: IMED-Z Fluid Status Monitor, K142503 The predicate has not been subject to a design-related recall. Reference Device: Impe… | 2015 |
| † | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | 2006 |
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 7 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 Re:Balans is intended for use under the direction of a physician, for the non-invasive monitoring of patients with fluid management-related health conditions. The device measures thoracic bioimpedance in patients to assist the physician in fluid management assessment.
The device is indicated for adult patients with fluid overload such as end-stage renal disease, and patients at risk of dehydration.
The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's fluid status.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243727: Re:Balans.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243727
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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