510(k) · Cleared
ClearedDolphin/IQ, Dolphin/4D and Dolphin/MAX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasonix, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 16, 2019 as substantially equivalent to K170859 (Viasonix, Ltd., 2017) after a 29-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- May 16, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993939 (2000). 9 ancestors in all, the oldest K931801 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK993939 Nicolet Eme Legend TC22Nicolet Biomedical · 2000
- 4 generations backK020754 Nicolet Pioneer TC8080Nicolet Biomedical · 2003
- 3 generations backK053648 Pioneer TC8080, Companion IiiViasys Neuro Care · 2006
- 2 generations backK060421 Sonara; Sonara/TekViasys Healthcare, Inc. · 2006 · Recalled
- 1 generation backK170859 Dolphin/IQ and Dolphin/4DViasonix, Ltd. · 2017
- This deviceK191023 Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK202742 Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993939 | Nicolet Eme Legend TC22 | Nicolet Biomedical | 2000 | — |
| −4 | K020754 | Nicolet Pioneer TC8080 | Nicolet Biomedical | 2003 | — |
| −3 | K053648 | Pioneer TC8080, Companion Iii | Viasys Neuro Care | 2006 | — |
| −2 | K060421 | Sonara; Sonara/Tek | Viasys Healthcare, Inc. | 2006 | 2 |
| −1 | K170859 | Dolphin/IQ and Dolphin/4D | Viasonix, Ltd. | 2017 | — |
| 0 (this device) | K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix, Ltd. | 2019 | — |
| +1 | K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | Viasonix, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K170859 | Dolphin/IQ and Dolphin/4DSummary page 9…892.1550 Product Code: IYN, ITX Device Class: Class II Predicate Devices: Dolphin/IQ and Dolphin/4D, K170859 5.2 DEVICE DESCRIPTION Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of non-invas… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | 2021 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K202742 (Viasonix, Ltd., 2021) has gone furthest, with 0 descendants of its own.
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?
Dolphin/IQ, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices
Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications.
Note : The Dolphin is to be used only by trained medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191023: Dolphin/IQ, Dolphin/4D and Dolphin/MAX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191023
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