510(k) · Cleared
ClearedColor Doppler Ultrasound System; Model: mEye1 and mEye2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Well.D Medical Electronics Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 20, 2018 as substantially equivalent to K113613 (Shantou Institute of Ultrasonic Instuments, 2012) after a 132-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 20, 2018
- Review
- 132 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935595 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 4 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 3 generations backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- 2 generations backK042326 Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004
- 1 generation backK113613 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2012
- This deviceK182165 Color Doppler Ultrasound System; Model: mEye1 and mEye2Shenzhen Well.D Medical Electronics Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −4 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −3 | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| −2 | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner | Ultrasonix Medical Corporation | 2004 | — |
| −1 | K113613 | Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2012 | — |
| 0 (this device) | K182165 | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Shenzhen Well.D Medical Electronics Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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 |
|---|---|---|---|
| * | K113613 | Digital Color Doppler Ultrasound Imaging SystemSummary page 7…play the images in the imaging operation modes of B, M, PWD and Color Doppler. 5. Identification of Predicate Device Predicate Device 510(k) Number: K113613 Product Name: Apogee 1200 Digital Color Doppler Ultrasound Imaging System 6. Non-Clinical Test Conclusion Non cli… | 2012 |
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 23 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K113613.
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. 2018, 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?
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182165: Color Doppler Ultrasound System; Model: mEye1 and mEye2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182165
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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