510(k) · Cleared
Cleared21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Totoku Electric Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 30, 2006 as substantially equivalent to K050617 (Totoku Electric Co., Ltd., 2005) after a 41-day review. Its family tree reaches back 5 generations to 2000. 5 later devices descend from it.
- Decided
- Nov 30, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000293 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 4 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 3 generations backK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
- 2 generations backK040695 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd. · 2004
- 1 generation backK050617 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I &…Totoku Electric Co., Ltd. · 2005
- This deviceK063198 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd. · 2006
- Descendant · cites it directly · 3 of its ownK081945 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008
- Descendant · 2 generations on · 2 of its ownK113443 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK133511 21.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation · 2013
- Descendant · 4 generations on · 0 of its ownK210345 2MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021
- Descendant · cites it directly · 0 of its ownK070370 21.3 Inch (54CM) Monochrome LCD Monitor MDL2122ATotoku Electric Co., Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008 · cites it directly3descendants
- K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011 · 2 generations on2descendants
- K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation · 2013 · 3 generations on1descendant
- K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021 · 4 generations on0descendants
- K07037021.3 Inch (54CM) Monochrome LCD Monitor MDL2122ATotoku Electric Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −4 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −3 | K021738 | Flat Panel Displays, ME Series & CCL Series | Totoku Electric Co., Ltd. | 2002 | — |
| −2 | K040695 | 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A) | Totoku Electric Co., Ltd. | 2004 | — |
| −1 | K050617 | 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HB | Totoku Electric Co., Ltd. | 2005 | — |
| 0 (this device) | K063198 | 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2) | Totoku Electric Co., Ltd. | 2006 | — |
| +1 | K081945 | 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A) | Totoku Electric Co., Ltd. | 2008 | — |
| +2 | K113443 | 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023) | Totoku Electric Co., Ltd. | 2011 | — |
| +3 | K133511 | 21.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025) | Jvckenwood Corporation | 2013 | — |
| +4 | K210345 | 2MP Monochrome LCD Monitor MS-S200 | Jvckenwood Corporation | 2021 | — |
| +1 | K070370 | 21.3 Inch (54CM) Monochrome LCD Monitor MDL2122A | Totoku Electric Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050617 | 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HBSummary page 1…(Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: MDL2109A (K050617) Device Description: MDL2121A (ME253i2) is a 21.3-inch Monochrome LCD Monitor th… | 2005 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K081945 (Totoku Electric Co., Ltd., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063198: 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063198
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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