510(k) Report

510(k) · Cleared

Cleared

Explorer CVS Transcranial Doppler

K990517510(k) TraditionalCleared Aug 1, 2000530-day reviewClass II21 CFR 892.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostic Medical Systems · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 1, 2000 as substantially equivalent to K974588 (Rimed, Ltd., 1998) and 4 other predicates after a 530-day review. Its family tree reaches back 1 generation to 1987. 1 of the 434 devices in its family, counting itself, has a Class I recall. 428 later devices descend from it.

Decided
Aug 1, 2000
Review
530 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K872292 (1987). 5 ancestors in all. 428 later devices descend from it, 1 citing it directly. 1 of the 434 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor2005: 1 descendant cleared2006: 1 descendant cleared2019: 29 descendants cleared2011: 1 descendant cleared2014: 1 descendant cleared2016: 7 descendants cleared2015: 6 descendants cleared2018: 17 descendants cleared2012: 1 descendant cleared2020: 22 descendants cleared2013: 3 descendants cleared2021: 41 descendants cleared, 1 with a Class I recall12017: 13 descendants cleared2022: 47 descendants cleared2023: 62 descendants cleared2025: 61 descendants cleared2026: 55 descendants cleared2024: 60 descendants clearedK872292 · Transpect Transcranial Doppler · Medasonics, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 14 descendants5 generations forward: 102 descendants6 generations forward: 113 descendants7 generations forward: 72 descendants8 generations forward: 58 descendants, 1 with a Class I recall19 generations forward: 25 descendants10 generations forward: 24 descendants11 generations forward: 12 descendants12 generations forward: 3 descendants13 generations forward: 1 descendant K872292 · Transpect Transcranial Doppler · Medasonics, Inc. · 19870+5+10
  1. Root · 1 generation backK872292 Transpect Transcranial DopplerMedasonics, Inc. · 1987
  2. This deviceK990517 Explorer CVS Transcranial DopplerDiagnostic Medical Systems · 2000
  3. Descendant · cites it directly · 427 of its ownK051739 Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model…Multigon Industries, Inc. · 2005
  4. Descendant · 2 generations on · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
  5. Descendant · 3 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
  7. Descendant · 4 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013

Showing 5 of 428 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12011: 12012: 12013: 32014: 12015: 62016: 72017: 132018: 172019: 292020: 222021: 412022: 472023: 622024: 602025: 612026: 55
2005high 62 (2023) · low 0 (2007)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 428 · See all
  • 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
  • K123270Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 4 generations on398descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872292Transpect Transcranial DopplerMedasonics, Inc.1987—
0 (this device)K990517Explorer CVS Transcranial DopplerDiagnostic Medical Systems2000—
+1K051739Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW…Multigon Industries, Inc.2005—
+2K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with…Axon Systems, Inc.2006—
+3K111520Ipc Powerease SystemMedtronic Xomed, Inc.20112
+4K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20131
+4K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201110
201210
201330
201410
201560
201670
2017130
2018170
2019290
2020220
2021411
2022470
2023620
2024600
2025610
2026550
FIG. 1 — Lineage of K990517, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K974588Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable Bilateral…
Summary page 1
…CVS Transcranial and Peripheral Vascular Doppler Classification Number: 90IYN Substantial Equivalence: Rimed Limited Intra-View Bilateral Transcranial Doppler Device (K974588), Medasonics, Inc. Neuroguard Transcranial Doppler Ultrasound System (K962796), Medasonics, Inc. Cerebrovascular Diagnostic Syste…
Rimed, Ltd.1998—
*K962796Neuroguard Transcranial Doppler Ultrasound System
Summary page 1
…N Substantial Equivalence: Rimed Limited Intra-View Bilateral Transcranial Doppler Device (K974588), Medasonics, Inc. Neuroguard Transcranial Doppler Ultrasound System (K962796), Medasonics, Inc. Cerebrovascular Diagnostic System; CDS (K914862), Biosound, Inc. Phase 2 Transcranial Probe (K894163), Acuson…
Medasonics, Inc.1997—
*K914862Cerebrovascular Diagnostic System; CDS
Summary page 1
…scranial Doppler Device (K974588), Medasonics, Inc. Neuroguard Transcranial Doppler Ultrasound System (K962796), Medasonics, Inc. Cerebrovascular Diagnostic System; CDS (K914862), Biosound, Inc. Phase 2 Transcranial Probe (K894163), Acuson Corp., Acuson S228 Transducer For Transcranial Doppler (K894163), M…
Medasonics, Inc.1992—
*K894163Phase 2 Transcranial Probe
Summary page 1
…euroguard Transcranial Doppler Ultrasound System (K962796), Medasonics, Inc. Cerebrovascular Diagnostic System; CDS (K914862), Biosound, Inc. Phase 2 Transcranial Probe (K894163), Acuson Corp., Acuson S228 Transducer For Transcranial Doppler (K894163), Medascnics, Inc. Transpect Transcranial Doppler (K8722…
Biosound, Inc.1989—
*K872292Transpect Transcranial Doppler
Summary page 1
…und, Inc. Phase 2 Transcranial Probe (K894163), Acuson Corp., Acuson S228 Transducer For Transcranial Doppler (K894163), Medascnics, Inc. Transpect Transcranial Doppler (K872292), and others. Device Description: The Explorer CVS device is & diagnostic ultrasonic Doppler. G. Intended Use:…
Medasonics, Inc.1987—

Also cleared against K974588: 3 other devices →

What descends from it? (428)

See all 428

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051739Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler…Multigon Industries, Inc.2005427

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K051739 (Multigon Industries, Inc., 2005) has gone furthest, with 427 descendants of its own.
  • 3 other devices also cite its predicate K974588.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (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.

Also cleared against K974588

3 other devices cite the same predicate.

  • K062578Digi-Lite TCD DeviceRimed, Ltd. · 2006
  • K060112Nodecrest Transcranical Doppler Ultrasound SystemNodecrest, LLC · 2006
  • K051739Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler Ultraound Probe, Model…Multigon Industries, Inc. · 2005

More from Diagnostic Medical Systems

2 FDA decisions under this applicant name. See the company

  • P000055Ubis 5000 Bone SonometerDiagnostic Medical Systems · 2001

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K990517 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990517: Explorer CVS Transcranial Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990517

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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