510(k) · Cleared
ClearedDynemo 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sometec, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Feb 24, 1998 as substantially equivalent to K884395 (Hewlett-Packard Co., 1989) and 2 other predicates after a 211-day review. Its family tree reaches back 1 generation to 1985. 1 of the 32 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it.
- Decided
- Feb 24, 1998
- Review
- 211 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K851426 (1985). 3 ancestors in all. 28 later devices descend from it, 4 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- This deviceK972798 Dynemo 3000Sometec, Inc. · 1998
- Descendant · cites it directly · 12 of its ownK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- Descendant · 2 generations on · 11 of its ownK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- Descendant · 3 generations on · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK031706 Cardioq, Model 9051-7005Deltex Medical · 2003
- Descendant · 4 generations on · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K112686 Next Gen Emg Endotracheal Tube4 generations on · 2012
Most influential descendants
Showing 5 of 28 · See all- K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003 · cites it directly12descendants
- K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003 · 2 generations on11descendants
- K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · 3 generations on8descendants
- K031706Cardioq, Model 9051-7005Deltex Medical · 2003 · cites it directly7descendants
- K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| 0 (this device) | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| +1 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| +2 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| +3 | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| +1 | K031706 | Cardioq, Model 9051-7005 | Deltex Medical | 2003 | — |
| +4 | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2011 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 DPW device
- #1 K251114 FloPatch FP120score 13.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K884395 | HP 21362B Transesophageal Ultrasound Imaging TransSummary page 1…n on of Predicate Device(s The DYNEMO 3000 is substantially equivalent to the following previously cleared and currently marketing devices: Hewilett Packard HP 21362B (K884395) Datascope ACCUCOM (K851426) Deltex EDM (K951369) vice iption The DYNEMO 3000 is a non-invasive hemodynamic diagnostic device d… | 1989 |
| * | K851426 | Accucom Cardiac Output MonitorSummary page 1…The DYNEMO 3000 is substantially equivalent to the following previously cleared and currently marketing devices: Hewilett Packard HP 21362B (K884395) Datascope ACCUCOM (K851426) Deltex EDM (K951369) vice iption The DYNEMO 3000 is a non-invasive hemodynamic diagnostic device designed to provide the anest… | 1985 |
| * | K951369 | EDMSummary page 1…bstantially equivalent to the following previously cleared and currently marketing devices: Hewilett Packard HP 21362B (K884395) Datascope ACCUCOM (K851426) Deltex EDM (K951369) vice iption The DYNEMO 3000 is a non-invasive hemodynamic diagnostic device designed to provide the anesthesiologist, cardiolo… | 1995 |
What descends from it? (28)
See all 284 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 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K021174 (Imagyn Surgical, 2003) has gone furthest, with 12 descendants of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for adult patients under anesthesia and/or in intensive care. Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO, pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status. Non-invasive, continuous…
Read the full statement (110 words)
Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for adult patients under anesthesia and/or in intensive care.
Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO, pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status.
Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for pediatric patients under anesthesia and/or in intensive care.
Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO; pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status.
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/K972798 · printed Nov 3, 2026
Cite this page
510(k) Report. “K972798: Dynemo 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K972798
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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