510(k) · Cleared
ClearedZoefluid Status Monitor (Model Zoe 2B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noninvasive Medical Technologies, Inc. · DSB Plethysmograph, Impedance
Cleared on Nov 13, 2012 as substantially equivalent to K042113 (Noninvasive Medical Technologies, LLC, 2004) after a 412-day review. Its family tree reaches back 2 generations to 1992. 19 later devices descend from it.
- Decided
- Nov 13, 2012
- Review
- 412 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922218 (1992). 3 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 1 generation backK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- This deviceK112830 Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK131509 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013
- Descendant · cites it directly · 17 of its ownK133301 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK142503 Imed-Z Fluid Status MonitorIntersection Medical, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK172507 SOZOImpediMed Limited · 2017
- Descendant · 4 generations on · 4 of its ownK193410 SOZO Body Fluid AnalyzerImpediMed Limited · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K131509Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013 · cites it directly18descendants
- K133301Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014 · cites it directly17descendants
- K142503Imed-Z Fluid Status MonitorIntersection Medical, Inc. · 2015 · 2 generations on10descendants
- K172507SOZOImpediMed Limited · 2017 · 3 generations on7descendants
- K193410SOZO Body Fluid AnalyzerImpediMed Limited · 2020 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| −1 | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| 0 (this device) | K112830 | Zoefluid Status Monitor (Model Zoe 2B) | Noninvasive Medical Technologies, Inc. | 2012 | — |
| +1 | K131509 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2013 | — |
| +1 | K133301 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2014 | — |
| +2 | K142503 | Imed-Z Fluid Status Monitor | Intersection Medical, Inc. | 2015 | — |
| +3 | K172507 | SOZO | ImpediMed Limited | 2017 | — |
| +4 | K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K042113 | Zoe Fluid Status MonitorSummary page 1…ufacturer Device Name 510-K Number Decision Date Noninvasive Medical ZOE Fluid Status Monitor K042113 Sept. 14, 2004 Technologies, Inc. Device Description: The ZOE Fluid Status Monitor is a non-invasive, battery p… | 2004 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131509 (Noninvasive Medical Technologies, Inc., 2013) has gone furthest, with 18 descendants of its own.
- 4 other devices also cite its predicate K042113.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ZOE Fluid Status Monitor is intended for patients:
With fluid management problems
Taking diuretic medication
Living with Heart Failure
Living with End-stage Renal Disease
Recovering from Coronary Artery Disease related event
Suffering from Recurrent Dehydration
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112830: Zoefluid Status Monitor (Model Zoe 2B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112830
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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