510(k) · Cleared
Recalled · 2009Sonara; Sonara/Tek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 3, 2006 as substantially equivalent to K051085 (Compumedics Germany Gmgh, 2005) and 2 other predicates after a 259-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 3, 2006
- Review
- 259 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K993939 (2000). 7 ancestors in all, the oldest K931801 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK993939 Nicolet Eme Legend TC22Nicolet Biomedical · 2000
- 2 generations backK020754 Nicolet Pioneer TC8080Nicolet Biomedical · 2003
- 1 generation backK053648 Pioneer TC8080, Companion IiiViasys Neuro Care · 2006
- This deviceK060421 Sonara; Sonara/TekViasys Healthcare, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK170859 Dolphin/IQ and Dolphin/4DViasonix, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK191023 Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK202742 Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K170859Dolphin/IQ and Dolphin/4DViasonix, Ltd. · 2017 · cites it directly2descendants
- K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd. · 2019 · 2 generations on1descendant
- K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993939 | Nicolet Eme Legend TC22 | Nicolet Biomedical | 2000 | — |
| −2 | K020754 | Nicolet Pioneer TC8080 | Nicolet Biomedical | 2003 | — |
| −1 | K053648 | Pioneer TC8080, Companion Iii | Viasys Neuro Care | 2006 | — |
| 0 (this device) | K060421 | Sonara; Sonara/Tek | Viasys Healthcare, Inc. | 2006 | — |
| +1 | K170859 | Dolphin/IQ and Dolphin/4D | Viasonix, Ltd. | 2017 | — |
| +2 | K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix, Ltd. | 2019 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K051085 | Doppler-Box | 2005 |
| * | K002533 | TCD 100M, PWD13 TransducerSummary page 1…pler-Box is a Transcranial Doppler Ultrasound device, providing similar data to the Sonara/tek device. -TCD lOOM (K002533) manufactured by Spencer Technologies. TCD lOOM is a l'ranscranial Doppler Ultrasound device, providi… | 2000 |
| * | K053648 | Pioneer TC8080, Companion IiiSummary page 1…scranial Doppler Ultrasound device, providing similar data to the Sonara device. -TC8080 Pioneer /Companion III (1(053648) manufactured by VIASYS HealthCare, Inc., Neurocare Group. The TC8080 Pioneer/… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170859 | Dolphin/IQ and Dolphin/4D | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2009 | Not classified | Z-0998-2009 | Device Design | Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by… |
| Jan 6, 2009 | Not classified | Z-0999-2009 | Device Design | Internal testing has identified several several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K170859 (Viasonix, Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K051085.
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.
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?
The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060421: Sonara; Sonara/Tek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060421
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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