510(k) · Cleared
ClearedZoe Fluid Status Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noninvasive Medical Technologies, LLC · DSB Plethysmograph, Impedance
Cleared on Sep 14, 2004 as substantially equivalent to K922218 (Renaissance Technology, Inc., 1992) and 1 other predicate after a 40-day review. Its family tree reaches back 1 generation to 1992. 76 later devices descend from it.
- Decided
- Sep 14, 2004
- Review
- 40 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922218 (1992). 2 ancestors in all. 76 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- This deviceK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- Descendant · cites it directly · 57 of its ownK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- Descendant · 2 generations on · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · 2 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · 3 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- Descendant · 4 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K083287Avivo Mobile Patient Management SystemCorventis, Inc. · 2009 · cites it directly57descendants
- K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · 2 generations on40descendants
- K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · 2 generations on38descendants
- K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 3 generations on30descendants
- K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| 0 (this device) | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| +1 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| +2 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| +2 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| +3 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| +4 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
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 |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K922218 | IQ SystemSummary page 1…ng marketed by NMT, LLC: Manufacturer Device Name 510-K Number Decision Date Renaissance IQ System' TM K922218 December 08, 1992 Technology, Inc. Renaissance IQ System TM K981720 February… | 1992 |
| * | K981720 | IQ SystemSummary page 1…te Renaissance IQ System' TM K922218 December 08, 1992 Technology, Inc. Renaissance IQ System TM K981720 February 08, 1998 Technology, Inc. * Device Description: The ZOETM Fluid Status Monitor is a non-invasive… | 1999 |
What descends from it? (76)
See all 765 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K083287 (Corventis, Inc., 2009) has gone furthest, with 57 descendants of its own.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
As with the predicate devices indicated in this submission (cardiac monitors employing impedance plethysmography {DSB}): The ZOETM Fluid Status Monitor is intended for: 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 The ZOETM Fluid Status Monitor is contraindicated for use with patients: With…
Read the full statement (121 words)
As with the predicate devices indicated in this submission (cardiac monitors employing impedance plethysmography {DSB}):
The ZOETM Fluid Status Monitor is intended for:
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
The ZOETM Fluid Status Monitor is contraindicated for use with patients:
With allergies to electrode hydrogel
Skin sensitivities to electrode hydrogel
Skin breakdown in areas on the chest where ZOE electrode placement is required.
This device is intended for use by qualified health care practitioners, 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/K042113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042113: Zoe Fluid Status Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042113
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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