510(k) · Cleared
ClearedPW Doppler Vascular Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koven Technology, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on May 11, 1995 after a 512-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 11, 1995
- Review
- 512 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK935994 PW Doppler Vascular ProbesKoven Technology, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK023024 Transvaginal Doppler Probe, Model 09-0006-02Vascular Control Systems, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK011863 VCS-a Series ClampVascular Control Systems, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK023154 VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and…Vascular Control Systems, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK032125 Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK031358 Transvaginal Doppler ProbeVascular Control Systems, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K023024Transvaginal Doppler Probe, Model 09-0006-02Vascular Control Systems, Inc. · 2002 · cites it directly2descendants
- K011863VCS-a Series ClampVascular Control Systems, Inc. · 2002 · cites it directly2descendants
- K023154VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02Vascular Control Systems, Inc. · 2002 · cites it directly1descendant
- K032125Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004 · 2 generations on0descendants
- K031358Transvaginal Doppler ProbeVascular Control Systems, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935994 | PW Doppler Vascular Probes | Koven Technology, Inc. | 1995 | — |
| +1 | K023024 | Transvaginal Doppler Probe, Model 09-0006-02 | Vascular Control Systems, Inc. | 2002 | — |
| +1 | K011863 | VCS-a Series Clamp | Vascular Control Systems, Inc. | 2002 | — |
| +1 | K023154 | VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02 | Vascular Control Systems, Inc. | 2002 | — |
| +2 | K032125 | Cstat, Models 09-0014-01 and 09-0014-02 | Vascular Control Systems, Inc. | 2004 | — |
| +2 | K031358 | Transvaginal Doppler Probe | Vascular Control Systems, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K023024 (Vascular Control Systems, Inc., 2002) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K935994 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935994: PW Doppler Vascular Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935994
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026