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 Jun 13, 2019 as substantially equivalent to K173801 (Shenzhen Delica Medical Equipment Co., Ltd., 2018) and 2 other predicates after a 128-day review. Its family tree reaches back 11 generations to 1991. 4 of the 97 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 13, 2019
- Review
- 128 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K902859 (1991). 96 ancestors in all, the oldest K790810 (1979). No later device cites it as a predicate yet. 4 of the 97 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- 2 generations backK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
- 1 generation backK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
- This deviceK190228 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2019
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)
- 3 generations backK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
- 2 generations backK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
- 1 generation backK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
- This deviceK190228 Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K093261 | MOVES | Thornhill Research, Inc. | 2010 | Class I |
| −3 | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | — |
| −2 | K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2017 | — |
| −1 | K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2018 | — |
| 0 (this device) | K190228 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 9 | 2 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 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.
4 devices in this family have a Class I recall. 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? (3)
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 14…2/9 4. Identification of Predicate Device Transcranial Doppler Ultrasound part: 510k Number: K173801 Product Name: Transcranial Doppler Ultrasound System Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd. N… | 2018 |
| * | K173916 | Finapres Nova Noninvasive Hemodynamic MonitorSummary page 14…ranial Doppler Ultrasound System Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd. Nano Core Part: (Finger Arterial Blood Pressure) 510k Number: K173916 Product Name: Noninvasive Blood Pressure Monitor Manufacturer: Finapres Medical Systems B.V. Upper Arm Cuff Meas… | 2018 |
| * | K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffSummary page 14…K173916 Product Name: Noninvasive Blood Pressure Monitor Manufacturer: Finapres Medical Systems B.V. Upper Arm Cuff Measurement Part: 510k Number: K182433 Product Name: Blood Pressure Cuff Manufacturer: Shenzhen Caremed Medical Technology Co.,Ltd 5. Non-Clinical Test C… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 20 of the 96 ancestors have a recall of any class; 4 have a Class I 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. 2019, 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?
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be: 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…
Read the full statement (284 words)
While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be:
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 robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.
While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject’s finger.
Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The system 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.
The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age.
The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190228: 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/K190228
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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