510(k) · Cleared
ClearedPocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Multigon Industries, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 28, 2005 as substantially equivalent to K882755 (Multigon Industries, Inc., 1988) and 6 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1987. 1 of the 437 devices in its family, counting itself, has a Class I recall. 427 later devices descend from it.
- Decided
- Jul 28, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K872292 (1987). 9 ancestors in all. 427 later devices descend from it, 1 citing it directly. 1 of the 437 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK872292 Transpect Transcranial DopplerMedasonics, Inc. · 1987
- 1 generation backK990517 Explorer CVS Transcranial DopplerDiagnostic Medical Systems · 2000
- This deviceK051739 Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model…Multigon Industries, Inc. · 2005
- Descendant · cites it directly · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- Descendant · 2 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 3 generations on · 396 of its ownK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
Showing 5 of 427 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 427 · See all- K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc. · 2006 · cites it directly426descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 2 generations on418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 3 generations on404descendants
- K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 3 generations on398descendants
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · 3 generations on396descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872292 | Transpect Transcranial Doppler | Medasonics, Inc. | 1987 | — |
| −1 | K990517 | Explorer CVS Transcranial Doppler | Diagnostic Medical Systems | 2000 | — |
| 0 (this device) | K051739 | Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW… | Multigon Industries, Inc. | 2005 | — |
| +1 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| +2 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +3 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
| +3 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +3 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 29 | 0 |
| 2020 | 22 | 0 |
| 2021 | 41 | 1 |
| 2022 | 47 | 0 |
| 2023 | 62 | 0 |
| 2024 | 60 | 0 |
| 2025 | 61 | 0 |
| 2026 | 55 | 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.
1 device in this family has a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | K882755 | Model 500V Vascular Spectrum AnalyzerSummary page 2…llowing cleared devices: Trade or Proprietary Name Manufacturer 510(k) Number Model 500V Transcranial Multigon Industries. K882755/A and Vascular Doppler Analyzer Intra-View Transcranial Doppler Rimed LTD K974588 Explorer CVS Transc… | 1988 |
| * | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral…Summary page 2…00V Transcranial Multigon Industries. K882755/A and Vascular Doppler Analyzer Intra-View Transcranial Doppler Rimed LTD K974588 Explorer CVS Transcranial Doppler Diagnostic Medical Sys. K990517 Ncurogard Transcranial Doppler Mcdasonics,In… | 1998 |
| * | K990517 | Explorer CVS Transcranial DopplerSummary page 2…scular Doppler Analyzer Intra-View Transcranial Doppler Rimed LTD K974588 Explorer CVS Transcranial Doppler Diagnostic Medical Sys. K990517 Ncurogard Transcranial Doppler Mcdasonics,Inc. K962796 Transpect Transcranial Doppler Medasonics,I… | 2000 |
| * | K962796 | Neuroguard Transcranial Doppler Ultrasound SystemSummary page 2…K974588 Explorer CVS Transcranial Doppler Diagnostic Medical Sys. K990517 Ncurogard Transcranial Doppler Mcdasonics,Inc. K962796 Transpect Transcranial Doppler Medasonics,Inc. K872292 Model TC4040 Pioneer Transcranial Eden EMS-Nicolet… | 1997 |
| * | K872292 | Transpect Transcranial DopplerSummary page 2…Sys. K990517 Ncurogard Transcranial Doppler Mcdasonics,Inc. K962796 Transpect Transcranial Doppler Medasonics,Inc. K872292 Model TC4040 Pioneer Transcranial Eden EMS-Nicolet K874684 Doppler Multidop Transcranial Doppler DWL… | 1987 |
| * | K874684 | TC2-64B Transcranial DopplerSummary page 2…. K962796 Transpect Transcranial Doppler Medasonics,Inc. K872292 Model TC4040 Pioneer Transcranial Eden EMS-Nicolet K874684 Doppler Multidop Transcranial Doppler DWL Electronische Sys K930458 Comparison of Multigon Model 500P Traunscra… | 1988 |
| * | K930458 | Multi-Dop LSummary page 2…K872292 Model TC4040 Pioneer Transcranial Eden EMS-Nicolet K874684 Doppler Multidop Transcranial Doppler DWL Electronische Sys K930458 Comparison of Multigon Model 500P Traunscranial and Vascular Doppler Spectrum Analyzer and Transducers with the predicate device… | 1995 |
What descends from it? (427)
See all 4271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and… | 2006 | 426 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K061639 (Axon Systems, Inc., 2006) has gone furthest, with 426 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?
The SOUP Transcranial and Vascular Doppler is to be used for the assessment of circulation in the adult cephalic ,(intracranial and extracranial) and peripheral vascular vessels. It is to be used by trained medical personnel in hospitals, clinics and physicians offices by prescriptions or doctors orders. It is not to be used for obstetrics.
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/K051739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051739: Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model 2MPB..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051739
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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