510(k) · Decided
DecidedEcom CV4 Endotracheal Cardiac Output Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagyn Medical Technologies, Inc. · DSB Plethysmograph, Impedance
Cleared on Sep 4, 2003 as substantially equivalent to K021174 (Imagyn Surgical, 2003) after a 23-day review. Its family tree reaches back 3 generations to 1985. 1 of the 20 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Sep 4, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851426 (1985). 8 ancestors in all. 11 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 2 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 1 generation backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- This deviceK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK131765 Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK112686 Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K112686 Next Gen Emg Endotracheal Tube2 generations on · 2012
Most influential descendants
Showing 5 of 11 · See all- K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · cites it directly8descendants
- K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · 2 generations on4descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 3 generations on1descendant
- K131765Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation · 2013 · cites it directly1descendant
- K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −2 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −1 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| 0 (this device) | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| +1 | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| +2 | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2011 | 10 |
| +3 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +1 | K131765 | Ecom Endotracheal Cardiac Output Monitor System | Conmed Corporation | 2013 | — |
| +2 | K112686 | Next Gen Emg Endotracheal Tube | Medtronic Xomed, Inc. | 2012 | Class I |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K021174 | Ecom Endotrachial Cardiac Output Monitor | 2003 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K094054 (Nuvasive, Inc., 2010) has gone furthest, with 8 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?
The ECOM CV4 (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 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 CV4 System will display 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032491: Ecom CV4 Endotracheal Cardiac Output Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032491
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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