510(k) · Cleared
ClearedDoppler-Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Germany Gmgh · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 5, 2005 as substantially equivalent to K002533 (Spencer Technologies, 2000) and 1 other predicate after a 7-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- May 5, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931801 (1995). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK931801 Multi-Dop XDantec Medical, Inc. · 1995
- This deviceK051085 Doppler-BoxCompumedics Germany Gmgh · 2005
- Descendant · cites it directly · 3 of its ownK060421 Sonara; Sonara/TekViasys Healthcare, Inc. · 2006 · Recalled
- 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
- Descendant · cites it directly · 0 of its ownK141462 Varia-NciNeurochaos Solutions, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K060421Sonara; Sonara/TekViasys Healthcare, Inc. · 2006 · cites it directly3descendants
- 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
- K141462Varia-NciNeurochaos Solutions, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931801 | Multi-Dop X | Dantec Medical, Inc. | 1995 | — |
| 0 (this device) | K051085 | Doppler-Box | Compumedics Germany Gmgh | 2005 | — |
| +1 | K060421 | Sonara; Sonara/Tek | Viasys Healthcare, Inc. | 2006 | 2 |
| +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 | — |
| +1 | K141462 | Varia-Nci | Neurochaos Solutions, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K002533 | TCD 100M, PWD13 TransducerSummary page 1…me: Doppler-Box Class: Regulatory Class II K002533 Predicate Device: Spencer Technologies; TOD 100M, PWD13 TRANSDUCER K931801… | 2000 |
| * | K931801 | Multi-Dop XSummary page 1…K002533 Predicate Device: Spencer Technologies; TOD 100M, PWD13 TRANSDUCER K931801 DWL Elektronische Systeme GmbH; Multi-DopO X Pe. oPerformance Standards… | 1995 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051085: Doppler-Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051085
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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