510(k) · Cleared
ClearedSOZO
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 Nov 25, 2019 as substantially equivalent to K172507 (ImpediMed Limited, 2017) and 1 other predicate after a 266-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Nov 25, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- QJB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K922218 (1992). 10 ancestors in all, the oldest K904109 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 6 generations backK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- 5 generations backK112830 Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc. · 2012
- 4 generations backK131509 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013
- 3 generations backK133301 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014
- 2 generations backK142503 Imed-Z Fluid Status MonitorIntersection Medical, Inc. · 2015
- 1 generation backK172507 SOZOImpediMed Limited · 2017
- This deviceK190529 SOZOImpediMed Limited · 2019
- Descendant · cites it directly · 0 of its ownK230531 SOZO ProImpediMed Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K230531SOZO ProImpediMed Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| −6 | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| −5 | K112830 | Zoefluid Status Monitor (Model Zoe 2B) | Noninvasive Medical Technologies, Inc. | 2012 | — |
| −4 | K131509 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2013 | — |
| −3 | K133301 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2014 | — |
| −2 | K142503 | Imed-Z Fluid Status Monitor | Intersection Medical, Inc. | 2015 | — |
| −1 | K172507 | SOZO | ImpediMed Limited | 2017 | — |
| 0 (this device) | K190529 | SOZO | ImpediMed Limited | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
Top candidate predicates for a new QJB device
- #1 K230531 SOZO Proscore 7.4 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K172507 | SOZOSummary page 4…Impedance Plethysmograph Regulatory Class: II Product Codes: QJB, DSB, MNW Predicate Device: ImpediMed Limited’s SOZO (K172507); ImpediMed Limited’s IMP SFB7 (K052319) Reference Devices: ImpediMed Limited’s SOZO (K17… | 2017 |
| * | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7Summary page 4…Product Codes: QJB, DSB, MNW Predicate Device: ImpediMed Limited’s SOZO (K172507); ImpediMed Limited’s IMP SFB7 (K052319) Reference Devices: ImpediMed Limited’s SOZO (K172122; K180126) Device Description The SOZO system consists o… | 2006 |
| † | K172122 | SOZO | 2017 |
| † | K180126 | SOZO | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230531 | SOZO Pro | 2023 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K230531 (ImpediMed Limited, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172507.
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. 2019, 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 system 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 system 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…
Read the full statement (186 words)
The SOZO system 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 system 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 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 as stated in the FDA summary.
https://510kreport.com/device/K190529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190529: SOZO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190529
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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