510(k) · Cleared
ClearedSOZO Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ImpediMed Limited · QJB Adjunct Monitor, Protein Calorie Malnutrition
Cleared on May 4, 2023 as substantially equivalent to K190529 (ImpediMed Limited, 2019) after a 66-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- May 4, 2023
- Review
- 66 days
- Class
- Class II
- Product code
- QJB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K922218 (1992). 11 ancestors in all, the oldest K904109 (1991). No later device cites it as a predicate yet.
- Root · 8 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 7 generations backK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- 6 generations backK112830 Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc. · 2012
- 5 generations backK131509 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013
- 4 generations backK133301 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014
- 3 generations backK142503 Imed-Z Fluid Status MonitorIntersection Medical, Inc. · 2015
- 2 generations backK172507 SOZOImpediMed Limited · 2017
- 1 generation backK190529 SOZOImpediMed Limited · 2019
- This deviceK230531 SOZO ProImpediMed Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| −7 | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| −6 | K112830 | Zoefluid Status Monitor (Model Zoe 2B) | Noninvasive Medical Technologies, Inc. | 2012 | — |
| −5 | K131509 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2013 | — |
| −4 | K133301 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2014 | — |
| −3 | K142503 | Imed-Z Fluid Status Monitor | Intersection Medical, Inc. | 2015 | — |
| −2 | K172507 | SOZO | ImpediMed Limited | 2017 | — |
| −1 | K190529 | SOZO | ImpediMed Limited | 2019 | — |
| 0 (this device) | K230531 | SOZO Pro | ImpediMed Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 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 QJB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K190529 | SOZOSummary page 4…h Regulatory Class II Product Code: QJB, DSB, MNW (Adjunct Monitor, Protein Calorie Malnutrition) Predicate Device: SOZO® (K190529) Reference Device: SOZO® (K193410) Purpose of the Special 510(k) Notice The purpose of the 510(k) is to clear the… | 2019 |
| † | 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 31 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.
How does its category compare?
All QJB devicesQJB Adjunct Monitor, Protein Calorie Malnutrition: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJB
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QJB
Too few QJB 510(k)s in any year since 2007 to give a median.
Recalls per year · QJB
No recall names QJB since 2007.
Adverse event reports per year · QJB
1in 2024
MAUDE reports naming product code QJB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SOZO Pro 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 SOZO Pro 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 •…
Read the full statement (187 words)
The SOZO Pro 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 SOZO Pro 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 SOZO Pro device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole plot, subject height, weight, age and sex.
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/K230531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230531: 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/K230531
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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