510(k) · Cleared
ClearedIntra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral Transcranial Doppler Device, Compact Mod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rimed, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 7, 1998 after a 241-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 441 devices in its family, counting itself, has a Class I recall. 440 later devices descend from it.
- Decided
- Aug 7, 1998
- Review
- 241 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
440 later devices descend from it, 4 citing it directly. 1 of the 441 devices in this family, counting this one, has a Class I recall.
- This deviceK974588 Intra-View Bilateral Transcranial Doppler Device, Smart-Lite…Rimed, Ltd. · 1998
- Descendant · cites it directly · 428 of its ownK990517 Explorer CVS Transcranial DopplerDiagnostic Medical Systems · 2000
- Descendant · cites it directly · 427 of its ownK051739 Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model…Multigon Industries, Inc. · 2005
- Descendant · 2 generations on · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- Descendant · 3 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
Showing 5 of 440 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 440 · See all- K990517Explorer CVS Transcranial DopplerDiagnostic Medical Systems · 2000 · cites it directly428descendants
- K051739Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler…Multigon Industries, Inc. · 2005 · cites it directly427descendants
- K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc. · 2006 · 2 generations on426descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 3 generations on418descendants
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 4 generations on404descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable… | Rimed, Ltd. | 1998 | — |
| +1 | K990517 | Explorer CVS Transcranial Doppler | Diagnostic Medical Systems | 2000 | — |
| +1 | K051739 | Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW… | Multigon Industries, Inc. | 2005 | — |
| +2 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| +3 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| +4 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 13 | 0 |
| 2018 | 19 | 0 |
| 2019 | 30 | 0 |
| 2020 | 22 | 0 |
| 2021 | 41 | 1 |
| 2022 | 49 | 0 |
| 2023 | 62 | 0 |
| 2024 | 60 | 0 |
| 2025 | 61 | 0 |
| 2026 | 56 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (440)
See all 4404 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K990517 (Diagnostic Medical Systems, 2000) has gone furthest, with 428 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:
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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974588 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974588: Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral Transcranial Doppler Device, Compact Mod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974588
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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