510(k) · Cleared
ClearedECOM™ Cardiac Output Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecom Medical, Inc. · DSB Plethysmograph, Impedance
Cleared on Sep 19, 2017 as substantially equivalent to K131765 (Conmed Corporation, 2013) and 1 other predicate after a 60-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Sep 19, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K851426 (1985). 14 ancestors in all, the oldest K771219 (1977). No later device cites it as a predicate yet.
- Root · 5 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 4 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 3 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- 2 generations backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- 1 generation backK131765 Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation · 2013
- This deviceK172196 ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −4 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −3 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| −2 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| −1 | K131765 | Ecom Endotracheal Cardiac Output Monitor System | Conmed Corporation | 2013 | — |
| 0 (this device) | K172196 | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K131765 | Ecom Endotracheal Cardiac Output Monitor SystemSummary page 5…any Name: ECOM Medical via acquisition of ECOM division of Conmed 510(k): K131765 Secondary Device Name: Well Lead Endobronchial Tubes Company Name: Well Lea… | 2013 |
| * | K092886 | Well Lead Endobronchial TubesSummary page 5…e: Well Lead Endobronchial Tubes Company Name: Well Lead Medical Device Instruments Ltd. 510(k): K092886 5-1 K172196… | 2010 |
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 32 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 14 ancestors have a recall of any class.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography. The ECOM System displays the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure. 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.…
Read the full statement (170 words)
The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography.
The ECOM System displays the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure.
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 with the 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 ECOM endotracheal tube.
The ECOM Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172196: ECOM™ Cardiac Output Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172196
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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