510(k) Report

510(k) · Cleared

Cleared

21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HB

K050617510(k) TraditionalCleared Apr 22, 200543-day reviewClass II21 CFR 892.2050

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

Totoku Electric Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Apr 22, 2005 as substantially equivalent to K040695 (Totoku Electric Co., Ltd., 2004) after a 43-day review. Its family tree reaches back 4 generations to 2000. 6 later devices descend from it.

Decided
Apr 22, 2005
Review
43 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K000293 (2000). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant clearedK000293 · Barco MGD 221 2 Megapixel Diagnostic Display · Barco N.V. · 2000K012099 · Monochrome Perfectly Flat Panel Displays, ME Series · Totoku Electric Co., Ltd. · 2001K021738 · Flat Panel Displays, ME Series & CCL Series · Totoku Electric Co., Ltd. · 2002K040695 · 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A) · Totoku Electric Co., Ltd. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K040695 · 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A) · Totoku Electric Co., Ltd. · 2004K021738 · Flat Panel Displays, ME Series & CCL Series · Totoku Electric Co., Ltd. · 2002K012099 · Monochrome Perfectly Flat Panel Displays, ME Series · Totoku Electric Co., Ltd. · 2001K000293 · Barco MGD 221 2 Megapixel Diagnostic Display · Barco N.V. · 20000+5
  1. Root · 4 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
  2. 3 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
  3. 2 generations backK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
  4. 1 generation backK040695 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd. · 2004
  5. This deviceK050617 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I &…Totoku Electric Co., Ltd. · 2005
  6. Descendant · cites it directly · 5 of its ownK063198 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd. · 2006
  7. Descendant · 2 generations on · 3 of its ownK081945 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008
  8. Descendant · 3 generations on · 2 of its ownK113443 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
  9. Descendant · 4 generations on · 1 of its ownK133511 21.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation · 2013
  10. Descendant · 5 generations on · 0 of its ownK210345 2MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12011: 12013: 12021: 1
2006high 1 (2006) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K06319821.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd. · 2006 · cites it directly5descendants
  • K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008 · 2 generations on3descendants
  • K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011 · 3 generations on2descendants
  • K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation · 2013 · 4 generations on1descendant
  • K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000293Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V.2000—
−3K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—
−2K021738Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd.2002—
−1K04069521,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd.2004—
0 (this device)K05061721.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HBTotoku Electric Co., Ltd.2005—
+1K06319821.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd.2006—
+2K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.2008—
+3K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd.2011—
+4K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation2013—
+5K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
201110
201310
202110
FIG. 1 — Lineage of K050617, 2000–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 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? (1)

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
*K04069521,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)
Summary page 1
…(Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: MDL2108A (K040695) Device Description: MDL2109A (ME251i) (DV2MM-HB) is a 21.3-inch Monochrome LCD Monitor…
Totoku Electric Co., Ltd.2004—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K06319821.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd.20065

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K063198 (Totoku Electric Co., Ltd., 2006) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Indications for use as stated in the FDA summary.

More from Totoku Electric Co., Ltd.

40 FDA decisions under this applicant name. See the company

  • K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
  • K11313621.3INCH (54CM)Color LCD Monitor CCL256I2(CL21256)Totoku Electric Co., Ltd. · 2011
  • K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011
  • K11260421.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
  • K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd. · 2011

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K050617 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050617: 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050617

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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