510(k) · Cleared
ClearedEcom Endotracheal Cardiac Output Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · DSB Plethysmograph, Impedance
Cleared on Dec 20, 2013 as substantially equivalent to K032491 (Imagyn Medical Technologies, Inc., 2003) after a 186-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Dec 20, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K851426 (1985). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 3 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 2 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- 1 generation backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- This deviceK131765 Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation · 2013
- Descendant · cites it directly · 0 of its ownK172196 ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172196ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −3 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −2 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| −1 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K131765 | Ecom Endotracheal Cardiac Output Monitor System | Conmed Corporation | 2013 | — |
| +1 | K172196 | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K032491 | Ecom CV4 Endotracheal Cardiac Output MonitorSummary page 1…ConMed Corporation via acquisition of Irnagyn Medical Technologies 51 0(k): K032491 E. Device Description The ECOM Endotracheal Cardiac Output Monitor System consists of a monitor, an endotrache… | 2003 |
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 |
|---|---|---|---|
| K172196 | ECOM™ Cardiac Output Monitoring System | 2017 | 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 28 years and passes through 5 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K172196 (Ecom Medical, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032491.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ECOM Endotracheal Cardiac Output Monitor System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an EGOM Endotracheal Tube. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.
The ECOM System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (00), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131765: Ecom Endotracheal Cardiac Output Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131765
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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