510(k) · Cleared
ClearedTransvaginal Doppler Probe, Model 09-0006-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Control Systems, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 26, 2002 as substantially equivalent to K935994 (Koven Technology, Inc., 1995) after a 15-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Sep 26, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935994 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935994 PW Doppler Vascular ProbesKoven Technology, Inc. · 1995
- This deviceK023024 Transvaginal Doppler Probe, Model 09-0006-02Vascular Control Systems, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK032125 Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK031358 Transvaginal Doppler ProbeVascular Control Systems, Inc. · 2003
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 |
|---|---|---|---|---|---|
| −1 | K935994 | PW Doppler Vascular Probes | Koven Technology, Inc. | 1995 | — |
| 0 (this device) | K023024 | Transvaginal Doppler Probe, Model 09-0006-02 | Vascular Control Systems, Inc. | 2002 | — |
| +1 | K032125 | Cstat, Models 09-0014-01 and 09-0014-02 | Vascular Control Systems, Inc. | 2004 | — |
| +1 | K031358 | Transvaginal Doppler Probe | Vascular Control Systems, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K935994 | PW Doppler Vascular ProbesSummary page 1…Company: Koven Technology, Inc. Device: PW Doppler Vascular Probes 5 1O(k): K935994 Date Cleared: May 11, 1995 4. A description of the device that is the subject of the 510(k), inc… | 1995 |
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?
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The Transvaginal Doppler Probe is intended for bilateral detection of uterine blood vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023024: Transvaginal Doppler Probe, Model 09-0006-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023024
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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