510(k) · Cleared
ClearedDeltex Medical KDP72 Doppler Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltex Medical Limited · DPT Probe, Blood-Flow, Extravascular
Cleared on Jan 22, 2015 as substantially equivalent to K073593 (Deltex Medical Limited, 2009) and 1 other predicate after a 105-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Jan 22, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 3
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 backK052989 DP240 240 Hour Doppler ProbeDeltex Medical · 2006
- 1 generation backK073593 I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C…Deltex Medical Limited · 2009
- This deviceK142932 Deltex Medical KDP72 Doppler ProbeDeltex 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 | 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 | — |
| 0 (this device) | K142932 | Deltex Medical KDP72 Doppler Probe | 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 DPT? 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 DPT device
- #1 K233076 Laser Speckle Imaging System (RFLSI CZW)score 8.6 · 5 generations · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073593 | I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour)…Summary page 6…The Deltex Medical Ltd KDP72 Doppler Probe is substantially equivalent in design, use and materials to the: Deltex Medical Ltd I2n Series Doppler Probe – K073593 Deltex Medical Ltd DP240 Doppler Probe – K052989 and the Sometic Dynemo 3000 - K972798, now Arrow Hemosonic probe Li… | 2009 |
| * | K052989 | DP240 240 Hour Doppler ProbeSummary page 6…substantially equivalent in design, use and materials to the: Deltex Medical Ltd I2n Series Doppler Probe – K073593 Deltex Medical Ltd DP240 Doppler Probe – K052989 and the Sometic Dynemo 3000 - K972798, now Arrow Hemosonic probe Like the I2n Series Probe is for use with the Deltex Medi… | 2006 |
| Kept off the family tree | K972798 | FDA’s K972798 is Dynemo 3000 Our reading of the summary gave K972798, FDA’s number for Dynemo 3000 (Sometec, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Arrow International, Inc. Hemosonic 100 Esophageal Probe”. Kept off the family tree. Summary page 6…materials to the: Deltex Medical Ltd I2n Series Doppler Probe – K073593 Deltex Medical Ltd DP240 Doppler Probe – K052989 and the Sometic Dynemo 3000 - K972798, now Arrow Hemosonic probe Like the I2n Series Probe is for use with the Deltex Medical CardioQ-EDM and CardioQ- EDM+ systems, K… | 1998 |
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.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DPT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DPT
201in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPT
22in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPT
52in 2025
MAUDE reports naming product code DPT, 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 | 3 | 55 | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 3 | 108 | 0 | 0 |
| 2014 | 3 | 201 | 0 | 5 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 21 |
| 2024 | 1 | — | 22 | 169 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.
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/K142932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142932: Deltex Medical KDP72 Doppler Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142932
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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