510(k) · Cleared
ClearedDolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
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 Jan 25, 2021 as substantially equivalent to K191023 (Viasonix, Ltd., 2019) after a 129-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jan 25, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K993939 (2000). 10 ancestors in all, the oldest K931801 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK993939 Nicolet Eme Legend TC22Nicolet Biomedical · 2000
- 5 generations backK020754 Nicolet Pioneer TC8080Nicolet Biomedical · 2003
- 4 generations backK053648 Pioneer TC8080, Companion IiiViasys Neuro Care · 2006
- 3 generations backK060421 Sonara; Sonara/TekViasys Healthcare, Inc. · 2006 · Recalled
- 2 generations backK170859 Dolphin/IQ and Dolphin/4DViasonix, Ltd. · 2017
- 1 generation backK191023 Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd. · 2019
- This deviceK202742 Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K993939 | Nicolet Eme Legend TC22 | Nicolet Biomedical | 2000 | — |
| −5 | K020754 | Nicolet Pioneer TC8080 | Nicolet Biomedical | 2003 | — |
| −4 | K053648 | Pioneer TC8080, Companion Iii | Viasys Neuro Care | 2006 | — |
| −3 | K060421 | Sonara; Sonara/Tek | Viasys Healthcare, Inc. | 2006 | 2 |
| −2 | K170859 | Dolphin/IQ and Dolphin/4D | Viasonix, Ltd. | 2017 | — |
| −1 | K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix, Ltd. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAXSummary page 10…21 CFR 1570, Product Codes: ITX, OQQ Device Class: Class II Primary Predicate Device: Dolphin/IQ , Dolphin/4D and Dolphin/MAX, K191023 Reference Device: EMS9UA, K122710 5.2 DEVICE D ESCRIPTION Dolphin/IQ, Dolphin/4D and Dolphin/MAX syste… | 2019 |
| † | K122710 | Transcranial Doppler with Robotic Probe Headband | 2013 |
| † | K180455 | NeuralBot | 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 21 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
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. 2021, 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
The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202742: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202742
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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