510(k) · Cleared
ClearedDeltex Medical CardioQ-EDM, Deltex 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 Jul 24, 2015 as substantially equivalent to K132139 (Deltex Medical Limited, 2013) and 1 other predicate after a 163-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Jul 24, 2015
- Review
- 163 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K851426 (1985). 7 ancestors in all. 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 backK031706 Cardioq, Model 9051-7005Deltex Medical · 2003
- 2 generations backK111542 Deltex Medical Cardioq EdmDeltex Medical Limited · 2011
- 1 generation backK132139 Deltex Medical Cardioq-Edm+Deltex Medical Limited · 2013
- This deviceK150347 Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+Deltex Medical Limited · 2015
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 | K031706 | Cardioq, Model 9051-7005 | Deltex Medical | 2003 | — |
| −2 | K111542 | Deltex Medical Cardioq Edm | Deltex Medical Limited | 2011 | — |
| −1 | K132139 | Deltex Medical Cardioq-Edm+ | Deltex Medical Limited | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K132139 | Deltex Medical Cardioq-Edm+Summary page 5…The Deltex Medical CardioQ‐EDM series are substantially equivalent in design, use and materials to the: Deltex Medical CardioQ‐EDM+, 510(k) number: K132139 and Deltex Medical CardioQ‐EDM, 510(k) number: K111542, only the software and related labeling has been updated to introduce a se… | 2013 |
| * | K111542 | Deltex Medical Cardioq EdmSummary page 5…ries are substantially equivalent in design, use and materials to the: Deltex Medical CardioQ‐EDM+, 510(k) number: K132139 and Deltex Medical CardioQ‐EDM, 510(k) number: K111542, only the software and related labeling has been updated to introduce a second formula to the formula and body surface area algor… | 2011 |
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 30 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K132139.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Deltex Medical CardioQ-EDM+ / Deltex Medical 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 Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM 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 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/K150347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150347: Deltex Medical CardioQ-EDM, 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/K150347
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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