510(k) Report

510(k) · Cleared

Cleared

Multi-Dop L

K930458510(k) TraditionalCleared Feb 3, 1995736-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

Dantec Medical, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Feb 3, 1995 after a 736-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 436 devices in its family, counting itself, has a Class I recall. 435 later devices descend from it.

Decided
Feb 3, 1995
Review
736 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

435 later devices descend from it, 2 citing it directly. 1 of the 436 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2005: 2 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2019: 29 descendants cleared2011: 1 descendant cleared2015: 8 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2016: 7 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 cleared1995200020052010201520202025
  1. This deviceK930458 Multi-Dop LDantec Medical, Inc. · 1995
  2. Descendant · cites it directly · 427 of its ownK051739 Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model…Multigon Industries, Inc. · 2005
  3. Descendant · 2 generations on · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
  4. Descendant · 3 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
  5. Descendant · 4 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
  6. Descendant · 4 generations on · 398 of its ownK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013

Showing 5 of 435 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12007: 12008: 12009: 12011: 12012: 12013: 32014: 12015: 82016: 72017: 132018: 172019: 292020: 222021: 412022: 472023: 622024: 602025: 612026: 55
2004high 62 (2023) · low 0 (2010)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 435 · 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
0 (this device)K930458Multi-Dop LDantec Medical, Inc.1995—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200710
200810
200910
201110
201210
201330
201410
201580
201670
2017130
2018170
2019290
2020220
2021411
2022470
2023620
2024600
2025610
2026550
FIG. 1 — Lineage of K930458, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (435)

See all 435

2 later devices cite 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
K041915Hemo-DopDwl Elektronische Systeme GmbH20046

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, K051739 (Multigon Industries, Inc., 2005) has gone furthest, with 427 descendants of its own.

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)—

More from Dantec Medical, Inc.

25 FDA decisions under this applicant name. See the company

  • K960503Dantec DuetDantec Medical, Inc. · 1996
  • K950314Dantec Monopolar Lumen Electrode (13R18 and 13R19)Dantec Medical, Inc. · 1996
  • K953999Dantec DA CapoDantec Medical, Inc. · 1995
  • K926363Multi-Dop SDantec Medical, Inc. · 1995
  • K931801Multi-Dop XDantec Medical, Inc. · 1995

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/K930458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930458: Multi-Dop L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930458

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026