510(k) · Cleared
ClearedPioneer TC8080, Companion Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Neuro Care · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 24, 2006 as substantially equivalent to K020754 (Nicolet Biomedical, 2003) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Jan 24, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K993939 (2000). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993939 Nicolet Eme Legend TC22Nicolet Biomedical · 2000
- 1 generation backK020754 Nicolet Pioneer TC8080Nicolet Biomedical · 2003
- This deviceK053648 Pioneer TC8080, Companion IiiViasys Neuro Care · 2006
- Descendant · cites it directly · 3 of its ownK060421 Sonara; Sonara/TekViasys Healthcare, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK170859 Dolphin/IQ and Dolphin/4DViasonix, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK191023 Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK202742 Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K060421Sonara; Sonara/TekViasys Healthcare, Inc. · 2006 · cites it directly3descendants
- K170859Dolphin/IQ and Dolphin/4DViasonix, Ltd. · 2017 · 2 generations on2descendants
- K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd. · 2019 · 3 generations on1descendant
- K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993939 | Nicolet Eme Legend TC22 | Nicolet Biomedical | 2000 | — |
| −1 | K020754 | Nicolet Pioneer TC8080 | Nicolet Biomedical | 2003 | — |
| 0 (this device) | K053648 | Pioneer TC8080, Companion Iii | Viasys Neuro Care | 2006 | — |
| +1 | K060421 | Sonara; Sonara/Tek | Viasys Healthcare, Inc. | 2006 | 2 |
| +2 | K170859 | Dolphin/IQ and Dolphin/4D | Viasonix, Ltd. | 2017 | — |
| +3 | K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix, Ltd. | 2019 | — |
| +4 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K864695 | ML TC2-64B Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…: Ultrasonic Pulsed Doppler Imaging System Classification Name: 21 CFR 882.1550: Product Code: YN 21 CFR 892.1579: Product Code: ITX Predicate Device(s): STO(k) Number: K864695 Manufacture; LEME Trade Name: ML TC2-64B STO(K) Number: K020754 Manufacture: Nicolet Biomedical Trade Name: Pioneer TC8080… | |
| * | K020754 | Nicolet Pioneer TC8080Summary page 1…1 CFR 882.1550: Product Code: YN 21 CFR 892.1579: Product Code: ITX Predicate Device(s): STO(k) Number: K864695 Manufacture; LEME Trade Name: ML TC2-64B STO(K) Number: K020754 Manufacture: Nicolet Biomedical Trade Name: Pioneer TC8080 STO(R) Number: KOT1224 Manufacture: Advanced Technology Laborator… | 2003 |
| * | K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060421 | Sonara; Sonara/Tek | 2006 | 3 |
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 6 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060421 (Viasys Healthcare, Inc., 2006) has gone furthest, with 3 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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K053648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053648: Pioneer TC8080, Companion Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053648
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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