510(k) · Cleared
ClearedDP240 240 Hour Doppler Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltex Medical · DPT Probe, Blood-Flow, Extravascular
Cleared on Mar 8, 2006 as substantially equivalent to K031706 (Deltex Medical, 2003) after a 135-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.
- Decided
- Mar 8, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K851426 (1985). 5 ancestors in all. 2 later devices descend from it, 2 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 deviceK052989 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 · cites it directly · 0 of its ownK142932 Deltex Medical KDP72 Doppler ProbeDeltex Medical Limited · 2015
Most influential descendants
Showing 2 of 2 · See allView 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) | 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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031706 | Cardioq, Model 9051-7005Summary page 1…predicate devices The DP240 is substantially equivalent to the following previously cleared devices: Deltex Medical CardioQ Probe as described in 510(k) No. K031706, Arrow International Hemosonic 100 Esophageal Probe as described in 510(k) No K972798 DP240 510(k)… | 2003 |
| 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 Hemosonic 100 Esophageal Probe”. Kept off the family tree. Summary page 1…Deltex Medical CardioQ Probe as described in 510(k) No. K031706, Arrow International Hemosonic 100 Esophageal Probe as described in 510(k) No K972798 DP240 510(k) Pqge 1 of 2 (4) Device De… | 1998 |
What descends from it? (2)
2 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 21 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K073593 (Deltex Medical Limited, 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K031706.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
When used in conjunction with the CardioQ cardiac output and fluid status monitoring system, the DP240 is designed to provide clinicians with real-time information about left-ventricular blood flow. The DP240 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 DP240 can be placed into the esophagus via oral or nasal insertion in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052989: DP240 240 Hour Doppler Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052989
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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