510(k) · Cleared
ClearedCardioq, Model 9051-7005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltex Medical · DPW Flowmeter, Blood, Cardiovascular
Cleared on Aug 6, 2003 as substantially equivalent to K951369 (Deltex Medical, 1995) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1985. 7 later devices descend from it.
- Decided
- Aug 6, 2003
- Review
- 65 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851426 (1985). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 1 generation backK972798 Dynemo 3000Sometec, Inc. · 1998
- This deviceK031706 Cardioq, Model 9051-7005Deltex Medical · 2003
- Descendant · cites it directly · 3 of its ownK111542 Deltex Medical Cardioq EdmDeltex Medical Limited · 2011
- Descendant · 2 generations on · 2 of its ownK132139 Deltex Medical Cardioq-Edm+Deltex Medical Limited · 2013
- Descendant · cites it directly · 2 of its ownK052989 DP240 240 Hour Doppler ProbeDeltex Medical · 2006
- Descendant · cites it directly · 1 of its ownK073593 I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C…Deltex Medical Limited · 2009
- Descendant · 2 generations on · 0 of its ownK172457 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111542Deltex Medical Cardioq EdmDeltex Medical Limited · 2011 · cites it directly3descendants
- K132139Deltex Medical Cardioq-Edm+Deltex Medical Limited · 2013 · 2 generations on2descendants
- K052989DP240 240 Hour Doppler ProbeDeltex Medical · 2006 · cites it directly2descendants
- K073593I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour)…Deltex Medical Limited · 2009 · cites it directly1descendant
- K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −1 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| 0 (this device) | K031706 | Cardioq, Model 9051-7005 | Deltex Medical | 2003 | — |
| +1 | K111542 | Deltex Medical Cardioq Edm | Deltex Medical Limited | 2011 | — |
| +2 | K132139 | Deltex Medical Cardioq-Edm+ | Deltex Medical Limited | 2013 | — |
| +1 | K052989 | DP240 240 Hour Doppler Probe | Deltex Medical | 2006 | — |
| +1 | K073593 | I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe… | Deltex Medical Limited | 2009 | — |
| +2 | K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 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 DPW? 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 13.7 · 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? (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 |
|---|---|---|---|
| * | K951369 | EDMSummary page 1…e CardioQ is substantially equivalent to the following previously cleared devices: Deltex Medical Esophageal Doppler Cardiac Function Monitor - 510(k) No. K951369 Arrow International Hemosonic 100 Cardiac Output Monitor (originally approved as the Sometec, Inc. DYNE… | 1995 |
| * | K972798 | Dynemo 3000Summary page 1…510(k) No. K951369 Arrow International Hemosonic 100 Cardiac Output Monitor (originally approved as the Sometec, Inc. DYNEMO 3000) - 510(k) No. K972798 Appendix 2A CardioQ 510(k)… | 1998 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111542 (Deltex Medical Limited, 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K951369.
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?
The CardioQ cardiac output and fluid status monitoring system is designed to provide
clinicians with real-time information about left-ventricular blood flow. The CardioQ is
designed to operate in a clinical setting in which the patients are under general
anesthesia or are sedated in the intensive care unit. The CardioQ offers the
anesthetist and intensive care physician with beat-to-beat data on cardiovascular
status and circulating blood volume, providing immediate feedback on the effect of
any therapeutic intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031706 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031706: Cardioq, Model 9051-7005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031706
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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