510(k) Report

510(k) · Cleared

Cleared

TC2-64B Transcranial Doppler

K874684510(k) TraditionalCleared Apr 25, 1988165-day reviewClass II21 CFR 892.1560

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

Carolina Medical Electronics · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Apr 25, 1988 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 429 devices in its family, counting itself, has a Class I recall. 428 later devices descend from it.

Decided
Apr 25, 1988
Review
165 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

428 later devices descend from it, 1 citing it directly. 1 of the 429 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 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 cleared1990200020102020
  1. This deviceK874684 TC2-64B Transcranial DopplerCarolina Medical Electronics · 1988
  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 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
0 (this device)K874684TC2-64B Transcranial DopplerCarolina Medical Electronics1988—
+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
200510
200610
201110
201210
201330
201410
201560
201670
2017130
2018170
2019290
2020220
2021411
2022470
2023620
2024600
2025610
2026550
FIG. 1 — Lineage of K874684, 1988–2026Source: 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 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? (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?

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

How does its category compare?

All IYO devices

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

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from Carolina Medical Electronics

11 FDA decisions under this applicant name. See the company

  • K914200Vascumap Medical Air PlethysmographCarolina Medical Electronics · 1991
  • K874685Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 1988
  • K864624Probe, Uptake, NuclearCarolina Medical Electronics · 1987
  • K843891Dopscan Plus DS1060Carolina Medical Electronics · 1985
  • K837329Sonacolor CD, Model 6300 Cardiac Doppler UltrasoundCarolina Medical Electronics · 1983

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https://510kreport.com/device/K874684 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874684: TC2-64B Transcranial Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874684

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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