510(k) · Cleared
ClearedI2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016
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 29, 2009 as substantially equivalent to K052989 (Deltex Medical, 2006) and 1 other predicate after a 405-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Jan 29, 2009
- Review
- 405 days
- Class
- Class II
- Product code
- DPT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K851426 (1985). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 3 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 2 generations backK031706 Cardioq, Model 9051-7005Deltex Medical · 2003
- 1 generation backK052989 DP240 240 Hour Doppler ProbeDeltex Medical · 2006
- This deviceK073593 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 1 of 1 · See all- K142932Deltex Medical KDP72 Doppler ProbeDeltex Medical Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −3 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −2 | K031706 | Cardioq, Model 9051-7005 | Deltex Medical | 2003 | — |
| −1 | K052989 | DP240 240 Hour Doppler Probe | Deltex Medical | 2006 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K052989 | DP240 240 Hour Doppler ProbeSummary page 2…The Deltex Medical Ltd I 2 n Series Doppler Probe is substantially equivalent in design, use and materials to the: Deltex Medical Ltd DP240 Hour Doppler Probe - K052989 and like the DP240 probe is for use with the Deltex Medical CardioQ system 9051-7005 - K031706' The Deltex Medical Ltd I 2n Ser… | 2006 |
| * | K031706 | Cardioq, Model 9051-7005Summary page 2…and materials to the: Deltex Medical Ltd DP240 Hour Doppler Probe - K052989 and like the DP240 probe is for use with the Deltex Medical CardioQ system 9051-7005 - K031706' The Deltex Medical Ltd I 2n Series Doppler Probe is made of the same materials as the Deltex Medical Ltd DP240 Hour Doppler Pro… | 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, Inc. Hemosonic 100 Esophageal Probe”. Kept off the family tree. Summary page 3…r Probe, is also substantially equivalent to the other Deltex Medical CardioQ Probe included in K031706 and the Arrow International, Inc, Hemosonic 100 Esophageal Probe, K972798. I:- ·. ' Device Description… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142932 | Deltex Medical KDP72 Doppler Probe | 2015 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K142932 (Deltex Medical Limited, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052989.
How does its category compare?
All DPT devicesDPT Probe, Blood-Flow, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I2is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073593 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073593: I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour), Models 9090-7015, 9090-7016.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073593
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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