510(k) · Cleared
ClearedTranscranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Delicate Electronics Co., Ltd. · OQQ Diagnostic Ultrasonic Transducer, Robotic
Cleared on May 13, 2010 as substantially equivalent to K060112 (Nodecrest, LLC, 2006) after a 301-day review. Its family tree reaches back 2 generations to 1998. 7 later devices descend from it.
- Decided
- May 13, 2010
- Review
- 301 days
- Class
- Class II
- Product code
- OQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974588 (1998). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974588 Intra-View Bilateral Transcranial Doppler Device, Smart-Lite…Rimed, Ltd. · 1998
- 1 generation backK060112 Nodecrest Transcranical Doppler Ultrasound SystemNodecrest, LLC · 2006
- This deviceK092164 Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers…Shenzhen Delicate Electronics Co., Ltd. · 2010
- Descendant · cites it directly · 5 of its ownK122710 Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK173801 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK180455 NeuralBotNeural Analytics, Inc. · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK254143 EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK213009 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122710Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013 · cites it directly5descendants
- K173801Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2018 · 2 generations on2descendants
- K180455NeuralBotNeural Analytics, Inc. · 2018 · 2 generations on1descendant
- K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026 · cites it directly0descendants
- K213009Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable… | Rimed, Ltd. | 1998 | — |
| −1 | K060112 | Nodecrest Transcranical Doppler Ultrasound System | Nodecrest, LLC | 2006 | — |
| 0 (this device) | K092164 | Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model… | Shenzhen Delicate Electronics Co., Ltd. | 2010 | — |
| +1 | K122710 | Transcranial Doppler with Robotic Probe Headband | Shenzhen Delicate Electronics Co., Ltd. | 2013 | — |
| +2 | K173801 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2018 | — |
| +2 | K180455 | NeuralBot | Neural Analytics, Inc. | 2018 | 1 |
| +1 | K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026 | — |
| +3 | K213009 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 OQQ? 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? (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.
What descends from it? (7)
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 12 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122710 (Shenzhen Delicate Electronics Co., Ltd., 2013) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OQQ devicesOQQ Diagnostic Ultrasonic Transducer, Robotic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OQQ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OQQ
Too few OQQ 510(k)s in any year since 2007 to give a median.
Recalls per year · OQQ
No recall names OQQ since 2007.
Adverse event reports per year · OQQ
No MAUDE report names OQQ 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 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?
The EMS9UA Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values 2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior…
Read the full statement (178 words)
The EMS9UA Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:
1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values
2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.
The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal.
The EMS9UA Transcranial Doppler is intended for use during:
a) Diagnostic exams
b) Surgical interventions
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
It is to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092164: Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092164
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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