Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Totoku Electric Co., Ltd. · Predicate Candidate Screening

40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

51 daysmedian FDA review time
224 days90th percentile
40clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K11344321.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)Totoku Electric Co., Ltd.2011-12-23320
K11313621.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)Totoku Electric Co., Ltd.2011-12-20570
K112145MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2Totoku Electric Co., Ltd.2011-11-071040
K11260421.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)Totoku Electric Co., Ltd.2011-10-27500
K11149621.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITORTotoku Electric Co., Ltd.2011-09-261180
K09272820.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)Totoku Electric Co., Ltd.2010-11-194410
K09094721.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODTotoku Electric Co., Ltd.2010-08-165000
K08194521.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)Totoku Electric Co., Ltd.2008-09-12660
K08105521.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)Totoku Electric Co., Ltd.2008-06-04510
K08105621.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)Totoku Electric Co., Ltd.2008-06-04510
K08095215-INCH (38 CM) COLOR LCD MONITOR CDL1576ATotoku Electric Co., Ltd.2008-05-29560
K08095119-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909ATotoku Electric Co., Ltd.2008-05-29560
K07179415M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS5Totoku Electric Co., Ltd.2008-02-112240
K0720661.3M MONOCHROME LCD MONITOR MDL1908ATotoku Electric Co., Ltd.2007-08-14180
K07206520.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)Totoku Electric Co., Ltd.2007-08-14180
K07037021.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122ATotoku Electric Co., Ltd.2007-03-09290
K06320020.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)Totoku Electric Co., Ltd.2006-12-07480
K06319921.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)Totoku Electric Co., Ltd.2006-12-04450
K06319821.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)Totoku Electric Co., Ltd.2006-11-30410
K06319721.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)Totoku Electric Co., Ltd.2006-11-30410
K0614475M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME55Totoku Electric Co., Ltd.2006-07-21570
K06096115-INCH (38CM) COLOR LCD MONITOR CDL1566ATotoku Electric Co., Ltd.2006-05-01240
K05219921.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (Totoku Electric Co., Ltd.2005-09-22410
K05140319-INCH (48CM) COLOR LCD MONITOR CDL1904ATotoku Electric Co., Ltd.2005-07-14440
K05133119-INCH (48 CM) COLOR LCD MONITOR CDL1902ATotoku Electric Co., Ltd.2005-06-27350
K05061920.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350ITotoku Electric Co., Ltd.2005-04-26470
K05061721.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, METotoku Electric Co., Ltd.2005-04-22430
K05061621.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250ITotoku Electric Co., Ltd.2005-04-21420
K05048520.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DTotoku Electric Co., Ltd.2005-04-07410
K04343020.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3Totoku Electric Co., Ltd.2005-01-28460
K0417375M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL210Totoku Electric Co., Ltd.2004-07-13150
K04069721.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)Totoku Electric Co., Ltd.2004-06-10850
K04069521,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)Totoku Electric Co., Ltd.2004-06-07820
K0316615M MEDICAL FLAT PANEL DISPLAY, ME511LTotoku Electric Co., Ltd.2004-04-233310
K0325553M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316Totoku Electric Co., Ltd.2004-02-261910
K030272FLAT PANEL DISPLAY, ME183LTotoku Electric Co., Ltd.2003-04-25880
K030276FLAT PANEL DISPLAYS, CDL SERIESTotoku Electric Co., Ltd.2003-04-25880
K030274MEDICAL FLAT PANEL DISPLAY, ME315LTotoku Electric Co., Ltd.2003-04-25880
K021738FLAT PANEL DISPLAYS, ME SERIES & CCL SERIESTotoku Electric Co., Ltd.2002-08-19830
K012099MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIESTotoku Electric Co., Ltd.2001-07-31260

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda