510(k) · Cleared
ClearedDeltex Medical Cardioq Edm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltex Medical Limited · DPW Flowmeter, Blood, Cardiovascular
Cleared on Oct 20, 2011 as substantially equivalent to K031706 (Deltex Medical, 2003) after a 140-day review. Its family tree reaches back 3 generations to 1985. 3 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851426 (1985). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 2 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 1 generation backK031706 Cardioq, Model 9051-7005Deltex Medical · 2003
- This deviceK111542 Deltex Medical Cardioq EdmDeltex Medical Limited · 2011
- Descendant · cites it directly · 2 of its ownK132139 Deltex Medical Cardioq-Edm+Deltex Medical Limited · 2013
- Descendant · cites it directly · 0 of its ownK172457 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
- Descendant · cites it directly · 0 of its ownK150347 Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+Deltex Medical Limited · 2015
Most influential descendants
Showing 3 of 3 · See all- K132139Deltex Medical Cardioq-Edm+Deltex Medical Limited · 2013 · cites it directly2descendants
- K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018 · cites it directly0descendants
- K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+Deltex Medical Limited · 2015 · cites it directly0descendants
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 | K031706 | Cardioq, Model 9051-7005 | Deltex Medical | 2003 | — |
| 0 (this device) | K111542 | Deltex Medical Cardioq Edm | Deltex Medical Limited | 2011 | — |
| +1 | K132139 | Deltex Medical Cardioq-Edm+ | Deltex Medical Limited | 2013 | — |
| +1 | K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018 | — |
| +1 | K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | Deltex Medical Limited | 2015 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 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? (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 |
|---|---|---|---|
| * | K031706 | Cardioq, Model 9051-7005Summary page 2…ited: Premarket Notification for CardioQ-EDM Esophageal Doppler Monitor Predicate Devices used to Demonstrate Substantial Equivalence: Deltex Medical CardioQ - K031706 Description, including Intended Use: The CardioQ-EDM system employs esophageal Doppler techniques using 4 MHz continuous wave u… | 2003 |
| † | K052989 | DP240 240 Hour Doppler Probe | 2006 |
What descends from it? (3)
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 26 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132139 (Deltex Medical Limited, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K031706.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM's beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious sedated patients in the operating room, intensive care unit, emergency room or ward.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111542: Deltex Medical Cardioq Edm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111542
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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