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 Jun 28, 2018 as substantially equivalent to K132139 (Deltex Medical Limited, 2013) and 2 other predicates after a 318-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 28, 2018
- Review
- 318 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K972320 (1997). 15 ancestors in all, the oldest K851426 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 5 generations backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- 4 generations backK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- 3 generations backK060387 Physioflow SystemVasocom, Inc. · 2008
- 2 generations backK103283 Physioflow EnduroVasocom, Inc. · 2010
- 1 generation backK140102 Physioflow Q-LinkVasocom, Inc. · 2014
- This deviceK172457 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −5 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| −4 | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| −3 | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
| −2 | K103283 | Physioflow Enduro | Vasocom, Inc. | 2010 | — |
| −1 | K140102 | Physioflow Q-Link | Vasocom, Inc. | 2014 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K132139 | Deltex Medical Cardioq-Edm+Summary page 4…Blood Flowmeter Product Code: DPW Regulation Number: 21 CFR 870.2100 Predicate Devices used to Demonstrate Substantial Equivalence: Primary Predicate - K132139 (Deltex Medical CardioQ EDM+ Esophageal Doppler Monitor, procode DPW) Secondary Predicate - K140102 (Manatec Biomedical PhysioFlo… | 2013 |
| * | K140102 | Physioflow Q-LinkSummary page 4…ices used to Demonstrate Substantial Equivalence: Primary Predicate - K132139 (Deltex Medical CardioQ EDM+ Esophageal Doppler Monitor, procode DPW) Secondary Predicate - K140102 (Manatec Biomedical PhysioFlow Q-Link Module, procode DSB) Description: The CardioQ-EDM series are medical instruments designed… | 2014 |
| * | K111542 | Deltex Medical Cardioq EdmSummary page 4…er (K132139) allows additional Pulse Pressure Waveform Analysis (PPWA) through arterial blood pressure based parameters slaved from a high-end monitor. The CardioQ-EDM (K111542) & Cardio EDM+ (K132139) have now been introduced with the addition of a USB Hub accessory and software modifications that allow… | 2011 |
| † | K060387 | Physioflow System | 2008 |
| † | K103283 | Physioflow Enduro | 2010 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 15 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. 2018, 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 series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series 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…
Read the full statement (119 words)
The CardioQ-EDM series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series 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.
The CardioQ-EDM series monitors when used in Flow Monitoring Mode (esophageal Doppler) or Pressure Monitoring Mode (EDM+ only) are intended for use with adult and pediatric patients. When the CardioQ-EDM series monitors are used for High-Definition Impedance CardioGraphy with a PhysioFlow Q-Link module the intended use is for adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172457: 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/K172457
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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