510(k) · Cleared
ClearedTranscranial Doppler Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Delica Medical Equipment Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 8, 2022 as substantially equivalent to K173801 (Shenzhen Delica Medical Equipment Co., Ltd., 2018) after a 291-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Jul 8, 2022
- Review
- 291 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974588 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK974588 Intra-View Bilateral Transcranial Doppler Device, Smart-Lite…Rimed, Ltd. · 1998
- 4 generations backK060112 Nodecrest Transcranical Doppler Ultrasound SystemNodecrest, LLC · 2006
- 3 generations backK092164 Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers…Shenzhen Delicate Electronics Co., Ltd. · 2010
- 2 generations backK122710 Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013
- 1 generation backK173801 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2018
- This deviceK213009 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable… | Rimed, Ltd. | 1998 | — |
| −4 | K060112 | Nodecrest Transcranical Doppler Ultrasound System | Nodecrest, LLC | 2006 | — |
| −3 | K092164 | Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model… | Shenzhen Delicate Electronics Co., Ltd. | 2010 | — |
| −2 | K122710 | Transcranial Doppler with Robotic Probe Headband | Shenzhen Delicate Electronics Co., Ltd. | 2013 | — |
| −1 | K173801 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2018 | — |
| 0 (this device) | K213009 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2022 | — |
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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K173801 | Transcranial Doppler Ultrasound SystemSummary page 6…be used in hospitals or healthcare facilities by doctors or trained healthcare professionals. 5. Identification of Predicate Device 510(k) Number: K173801 Product Name: Transcranial Doppler Ultrasound System 6. Non-Clinical Test Conclusion Non clinical tests wer… | 2018 |
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 24 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K173801.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
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 hemo dynamically 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…
Read the full statement (186 words)
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 hemo dynamically 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.
Transcranial Doppler is intended for use during:
1) Diagnostic exams;
2) 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.
This device is intended for use by qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics. Mode of Operation is Pulsed Wave (PW) Doppler mode
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/K213009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213009: Transcranial Doppler Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213009
Report an extraction error
Are you the manufacturer?
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