510(k) · Cleared
ClearedSOZO Pro
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 May 4, 2023 as substantially equivalent to K180126 (ImpediMed Limited, 2018) after a 66-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- May 4, 2023
- Review
- 66 days
- Class
- Class II
- Product code
- OBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904109 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- 6 generations backK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 5 generations backK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- 4 generations backK100811 Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011
- 3 generations backK130338 Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013
- 2 generations backK172122 SOZOImpediMed Limited · 2017
- 1 generation backK180126 SOZOImpediMed Limited · 2018 · Recalled
- This deviceK230530 SOZO ProImpediMed Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| −6 | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | Impedimed Pty, Ltd. | 2006 | — |
| −5 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| −4 | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 | ImpediMed Limited | 2011 | — |
| −3 | K130338 | Impedimed - Bis Extra Cellular Fluid Analysis | ImpediMed Limited | 2013 | — |
| −2 | K172122 | SOZO | ImpediMed Limited | 2017 | — |
| −1 | K180126 | SOZO | ImpediMed Limited | 2018 | 1 |
| 0 (this device) | K230530 | SOZO Pro | ImpediMed Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 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 K253224 MySOZO Software version 6.0.1.2 (SW version…score 13.5 · 10 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 |
|---|---|---|---|
| * | K180126 | SOZOSummary page 4…graph Regulatory Class II Product Code: OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity) Predicate Device: SOZO® (K180126) Reference Device: SOZO® (K193410) Purpose of the Special 510(k) Notice The purpose of the 510(k) is to clear the… | 2018 |
| † | K193410 | SOZO Body Fluid Analyzer | 2020 |
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 32 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
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. 2023, 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?
The SOZO Pro has the following uses:
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230530: SOZO Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230530
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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