510(k) · Cleared
ClearedSOZO Body Fluid Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ImpediMed Limited · DSB Plethysmograph, Impedance
Cleared on Oct 2, 2020 as substantially equivalent to K172507 (ImpediMed Limited, 2017) after a 298-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it.
- Decided
- Oct 2, 2020
- Review
- 298 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922218 (1992). 8 ancestors in all. 4 later devices descend 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 deviceK193410 SOZO Body Fluid AnalyzerImpediMed Limited · 2020
- Descendant · cites it directly · 3 of its ownK203473 SOZOImpediMed Limited · 2021
- Descendant · 2 generations on · 2 of its ownK232089 SOZO ProImpediMed Limited · 2023
- Descendant · 3 generations on · 0 of its ownK260224 MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited · 2026
- Descendant · 3 generations on · 0 of its ownK253224 MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited · 2026
Most influential descendants
Showing 4 of 4 · See all- K203473SOZOImpediMed Limited · 2021 · cites it directly3descendants
- K232089SOZO ProImpediMed Limited · 2023 · 2 generations on2descendants
- K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited · 2026 · 3 generations on0descendants
- K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited · 2026 · 3 generations on0descendants
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) | K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020 | — |
| +1 | K203473 | SOZO | ImpediMed Limited | 2021 | — |
| +2 | K232089 | SOZO Pro | ImpediMed Limited | 2023 | — |
| +3 | K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited | 2026 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K172507 | SOZOSummary page 4…Impedance Plethysmograph Regulatory Class: II Product Code: DSB Predicate Device: ImpediMed Limited’s SOZO (K172507) Purpose of the Traditional 510(k) Notice The purpose of the 510(k) is to clear modifications including updates to software arc… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203473 | SOZO | 2021 | 3 |
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 28 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K203473 (ImpediMed Limited, 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K172507.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 SOZO Body Fluid Analyzer 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193410: SOZO Body Fluid Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193410
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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