510(k) · Cleared
ClearedEmp-2100 Full Digital Ultrasound Diagnostic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Emperor Electronic Technology Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 16, 2008 as substantially equivalent to K060949 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) after a 14-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Jul 16, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K934139 (1995). 17 ancestors in all, the oldest K852159 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 4 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 3 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 2 generations backK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- 1 generation backK060949 DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- This deviceK081873 Emp-2100 Full Digital Ultrasound Diagnostic DeviceShenzhen Emperor Electronic Technology Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK170856 CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd · 2017
- Descendant · 2 generations on · 0 of its ownK232895 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd · 2024
- Descendant · cites it directly · 0 of its ownK100079 Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See all- K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd · 2017 · cites it directly1descendant
- K232895B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd · 2024 · 2 generations on0descendants
- K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −4 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −3 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −2 | K042540 | Philips IU22 Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| −1 | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| 0 (this device) | K081873 | Emp-2100 Full Digital Ultrasound Diagnostic Device | Shenzhen Emperor Electronic Technology Co., Ltd. | 2008 | — |
| +1 | K170856 | CMS600P2 B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2017 | — |
| +2 | K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2024 | — |
| +1 | K100079 | Digital Ultrasound Scanner | Shenzhen Well.D Medical Electronics Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging SystemSummary page 2…al. This device is not intended for home use. 5. Predicate Device: DP-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers K-number: K060949 Product Code: IYO Intended Use: The system is a general-purpose, fully digital ultrasound system for abdominal,… | 2006 |
What descends from it? (3)
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 13 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K170856 (Contec Medical Systems Co.,Ltd, 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K060949.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081873: Emp-2100 Full Digital Ultrasound Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081873
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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