510(k) · Cleared
ClearedMySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ImpediMed Limited · OBH Monitor, Extracellular Fluid, Lymphedema, Extremity
Cleared on Jan 28, 2026 as substantially equivalent to K232089 (ImpediMed Limited, 2023) after a 121-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jan 28, 2026
- Review
- 121 days
- Class
- Class II
- Product code
- OBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K922218 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 6 generations between
- 3 generations backK193410 SOZO Body Fluid AnalyzerImpediMed Limited · 2020
- 2 generations backK203473 SOZOImpediMed Limited · 2021
- 1 generation backK232089 SOZO ProImpediMed Limited · 2023
- This deviceK253224 MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited · 2026
Show all 10 generations
- Root · 10 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 9 generations backK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- 8 generations backK112830 Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc. · 2012
- 7 generations backK131509 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013
- 6 generations backK133301 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014
- 5 generations backK142503 Imed-Z Fluid Status MonitorIntersection Medical, Inc. · 2015
- 4 generations backK172507 SOZOImpediMed Limited · 2017
- 3 generations backK193410 SOZO Body Fluid AnalyzerImpediMed Limited · 2020
- 2 generations backK203473 SOZOImpediMed Limited · 2021
- 1 generation backK232089 SOZO ProImpediMed Limited · 2023
- This deviceK253224 MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| −9 | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| −8 | K112830 | Zoefluid Status Monitor (Model Zoe 2B) | Noninvasive Medical Technologies, Inc. | 2012 | — |
| −7 | K131509 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2013 | — |
| −6 | K133301 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2014 | — |
| −5 | K142503 | Imed-Z Fluid Status Monitor | Intersection Medical, Inc. | 2015 | — |
| −4 | K172507 | SOZO | ImpediMed Limited | 2017 | — |
| −3 | K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020 | — |
| −2 | K203473 | SOZO | ImpediMed Limited | 2021 | — |
| −1 | K232089 | SOZO Pro | ImpediMed Limited | 2023 | — |
| 0 (this device) | K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | 2026 | — |
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 OBH? 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 OBH device
- #1 K230530 SOZO Proscore 7.1 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K232089 | SOZO ProSummary page 5…Regulatory Class II Product Code: DSB (Cardiac Electrophysiology, Diagnostics and Monitoring) Predicate Device: SOZO Pro® (K232089) Reference Device: SOZO(K180126) Purpose of the Traditional 510(k) Notice The purpose of the 510(k) is to clear t… | 2023 |
| † | K180126 | SOZO | 2018 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K232089.
How does its category compare?
All OBH devicesOBH Monitor, Extracellular Fluid, Lymphedema, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OBH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OBH
Too few OBH 510(k)s in any year since 2007 to give a median.
Recalls per year · OBH
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBH
No MAUDE report names OBH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MySOZO Software version 6.0.1.2 has the following uses: The MySOZO Software version 6.0.1.2 is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data. For adult human patients at risk of lymphedema: A…
Read the full statement (348 words)
MySOZO Software version 6.0.1.2 has the following uses:
The MySOZO Software version 6.0.1.2 is intended for adult patients living with heart failure.
This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
For adult human patients at risk of lymphedema:
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.
The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.
The MySOZO Software version 6.0.1.2 may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).
The MySOZO Software version 6.0.1.2 may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:
• Fat mass
• Fat-free mass
• Total body water
• Intracellular fluid
• Extracellular fluid
• Skeletal muscle mass
The following outputs are also presented:
• Body Mass Index (BMI)
• Basal metabolic rate (BMR; based on Mifflin - St. Jeor's algorithm) displayed in calories per day
• Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.
The MySOZO Software version 6.0.1.2 device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xe), and impedance (Z), which are used to estimate the above body composition parameters. The device/ software will also display the Cole plot, subject height, weiqht aqe and sex.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253224 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253224: MySOZO Software version 6.0.1.2 (SW version 6.0.1.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253224
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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