510(k) · Cleared
ClearedEdema Guard Monitor (EGM) CardioSet-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardioset Medical, Ltd. · DSB Plethysmograph, Impedance
Cleared on Sep 9, 2025 as substantially equivalent to K133301 (Noninvasive Medical Technologies, Inc., 2014) after a 166-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Sep 9, 2025
- Review
- 166 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922218 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK922218 IQ SystemRenaissance Technology, Inc. · 1992
- 4 generations backK042113 Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC · 2004
- 3 generations backK112830 Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc. · 2012
- 2 generations backK131509 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2013
- 1 generation backK133301 Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc. · 2014
- This deviceK250922 Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922218 | IQ System | Renaissance Technology, Inc. | 1992 | — |
| −4 | K042113 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, LLC | 2004 | — |
| −3 | K112830 | Zoefluid Status Monitor (Model Zoe 2B) | Noninvasive Medical Technologies, Inc. | 2012 | — |
| −2 | K131509 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2013 | — |
| −1 | K133301 | Zoe Fluid Status Monitor | Noninvasive Medical Technologies, Inc. | 2014 | — |
| 0 (this device) | K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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 |
|---|---|---|---|
| * | K133301 | Zoe Fluid Status MonitorSummary page 5…Number: 21 CFR 870.2770 Product Code: DSB Predicate: Predicate Trade Name: Zoe Fluid Status Monitor Predicate #: K133301 K250922… | 2014 |
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 33 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K133301.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 EGM CardioSet-001 is intended for patients with any of the following conditions:
● With fluid management problems
● Taking diuretic medication
● Living with heart failure
● Suffering or recovering from a coronary artery disease-related event
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 both the inpatient and outpatient setting.
The EGM CardioSet-001 reading is intended to be used as an adjunct parameter to standard clinical assessment methods and should not be the sole input used to guide treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250922: Edema Guard Monitor (EGM) CardioSet-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250922
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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