510(k) Report

510(k) · Cleared

Cleared

20.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)

K092728510(k) TraditionalCleared Nov 19, 2010441-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 Nov 19, 2010 as substantially equivalent to K021738 (Totoku Electric Co., Ltd., 2002) after a 441-day review. Its family tree reaches back 3 generations to 2000. 8 later devices descend from it.

Decided
Nov 19, 2010
Review
441 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K000293 (2000). 8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2022: 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. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants K021738 · 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
  1. Root · 3 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
  2. 2 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
  3. 1 generation backK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
  4. This deviceK092728 20.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd. · 2010
  5. Descendant · cites it directly · 5 of its ownK151134 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation · 2015
  6. Descendant · 2 generations on · 4 of its ownK161895 2MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation · 2016
  7. Descendant · 3 generations on · 1 of its ownK182539 2MP Color LCD Monitor CL-R211Jvckenwood Corporation · 2018
  8. Descendant · 3 generations on · 1 of its ownK173434 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300Jvckenwood Corporation · 2017
  9. Descendant · 4 generations on · 0 of its ownK241105 3MP Color LCD Monitor (CL-S301)Jvckenwood Corporation · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 22015: 12016: 12017: 12018: 12022: 12024: 1
2014high 2 (2014) · low 0 (2019)2026

Most influential descendants

Showing 5 of 8 · See all
  • K15113421.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation · 2015 · cites it directly5descendants
  • K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation · 2016 · 2 generations on4descendants
  • K1825392MP Color LCD Monitor CL-R211Jvckenwood Corporation · 2018 · 3 generations on1descendant
  • K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300Jvckenwood Corporation · 2017 · 3 generations on1descendant
  • K2411053MP Color LCD Monitor (CL-S301)Jvckenwood Corporation · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000293Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V.2000—
−2K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—
−1K021738Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd.2002—
0 (this device)K09272820.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd.2010—
+1K15113421.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation2015—
+2K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation2016—
+3K1825392MP Color LCD Monitor CL-R211Jvckenwood Corporation2018—
+3K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300Jvckenwood Corporation2017—
+4K2411053MP Color LCD Monitor (CL-S301)Jvckenwood Corporation2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201510
201610
201710
201810
202210
202410
FIG. 1 — Lineage of K092728, 2000–2024Source: 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
*K021738Flat Panel Displays, ME Series & CCL Series
Summary page 1
…ec. 892.2050 Picture Archiving and Communication System) Predicate Device: 20.1-inch 2-Megapixel Color LCD Display CCL202 (CDL2005A) (K021738) Device Description: CCL208 (CDL2O13A) is a 20.1-inch (51 cm) Color LCD monitor…
Totoku Electric Co., Ltd.2002—

Also cleared against K021738: 5 other devices →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K15113421.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation20155
K14253621.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)Jvckenwood Corporation20140
K14254024.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)Jvckenwood Corporation20140

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 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K151134 (Jvckenwood Corporation, 2015) has gone furthest, with 5 descendants of its own.
  • 5 other devices also cite its predicate K021738.

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. 2010, this device’s year, is highlighted.

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?

20.1-inch (51cm) Color LCD Monitor CCL208 (CDL2O13A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

Indications for use as stated in the FDA summary.

Also cleared against K021738

5 other devices cite the same predicate.

  • K14307620.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)Jvckenwood Corporation · 2014
  • K110108ModalixxAmpronix, Inc. · 2011
  • K06106120.1-Inch (51CM) Color LCD Monitor CDL2009A (CCL204)Tokotu Electric Co., Ltd. · 2006
  • K04069721.3-Inch (54CM) Color LCD Monitor CCL212 (CDL2107A)Totoku Electric Co., Ltd. · 2004
  • K04069521,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd. · 2004

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/K092728 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092728: 20.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092728

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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