510(k) · Cleared
ClearedEchoheart Transvaginal Doppler Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Doppler Systems, Inc. · HEK Monitor, Heart Sound, Fetal, Ultrasonic
Cleared on Apr 10, 2006 as substantially equivalent to K024197 (Summit Doppler Systems, Inc., 2003) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 10, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- HEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930200 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 1 generation backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- This deviceK060410 Echoheart Transvaginal Doppler ProbeSummit Doppler Systems, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −2 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −1 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| 0 (this device) | K060410 | Echoheart Transvaginal Doppler Probe | Summit Doppler Systems, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 HEK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K024197 | Lifedop DopplerSummary page 1…, Colorado Bothell, WA 98011 LifeDop Doppler w/ 3MHz Probe HDI 1000 Diagnostic w/ Transvaginal Probe K024197, Cleared 1/3/03 K961073, Cleared 2/19/97 Technologies Summary: Doppler ultrasound technology is the same as substant… | 2003 |
| * | K961073 | Atlas 2.0 & Hitachi 2.0 (a Trade Name Subject to Change)Summary page 1…l, WA 98011 LifeDop Doppler w/ 3MHz Probe HDI 1000 Diagnostic w/ Transvaginal Probe K024197, Cleared 1/3/03 K961073, Cleared 2/19/97 Technologies Summary: Doppler ultrasound technology is the same as substantially equivalent devices… | 1997 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 6 other devices also cite its predicate K024197.
How does its category compare?
All HEK devicesHEK Monitor, Heart Sound, Fetal, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEK
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HEK
Too few HEK 510(k)s in any year since 2007 to give a median.
Recalls per year · HEK
No recall names HEK since 2007.
Adverse event reports per year · HEK
No MAUDE report names HEK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060410 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060410: Echoheart Transvaginal 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/K060410
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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