510(k) · Cleared
Cleared21.3 Inch (54 CM) Color LCD Monitor CCL258I2 (CL21258)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jvckenwood Corporation · LLZ System, Image Processing, Radiological
Cleared on Dec 3, 2013 as substantially equivalent to K113136 (Totoku Electric Co., Ltd., 2011) after a 47-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Dec 3, 2013
- Review
- 47 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000293 (2000). No later device cites it as a predicate yet.
- Root · 8 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 7 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 6 generations backK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
- 5 generations backK040697 21.3-Inch (54CM) Color LCD Monitor CCL212 (CDL2107A)Totoku Electric Co., Ltd. · 2004
- 4 generations backK050616 21.3-Inch (54CM) Color LCD Monitor, Models CDL2113A, CCL250I &…Totoku Electric Co., Ltd. · 2005
- 3 generations backK063199 21.3-Inch (54CM) Color LCD Monitor CDL2120A (CCL252I2)Totoku Electric Co., Ltd. · 2006
- 2 generations backK081055 21.3 (54CM) 2M Color LCD Monitor CCL254I2 (CDL2125A)Totoku Electric Co., Ltd. · 2008
- 1 generation backK113136 21.3INCH (54CM)Color LCD Monitor CCL256I2(CL21256)Totoku Electric Co., Ltd. · 2011
- This deviceK133181 21.3 Inch (54 CM) Color LCD Monitor CCL258I2 (CL21258)Jvckenwood Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −7 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −6 | K021738 | Flat Panel Displays, ME Series & CCL Series | Totoku Electric Co., Ltd. | 2002 | — |
| −5 | K040697 | 21.3-Inch (54CM) Color LCD Monitor CCL212 (CDL2107A) | Totoku Electric Co., Ltd. | 2004 | — |
| −4 | K050616 | 21.3-Inch (54CM) Color LCD Monitor, Models CDL2113A, CCL250I & DV2MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −3 | K063199 | 21.3-Inch (54CM) Color LCD Monitor CDL2120A (CCL252I2) | Totoku Electric Co., Ltd. | 2006 | — |
| −2 | K081055 | 21.3 (54CM) 2M Color LCD Monitor CCL254I2 (CDL2125A) | Totoku Electric Co., Ltd. | 2008 | — |
| −1 | K113136 | 21.3INCH (54CM)Color LCD Monitor CCL256I2(CL21256) | Totoku Electric Co., Ltd. | 2011 | — |
| 0 (this device) | K133181 | 21.3 Inch (54 CM) Color LCD Monitor CCL258I2 (CL21258) | Jvckenwood Corporation | 2013 | — |
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 |
|---|---|---|---|
| * | K113136 | 21.3INCH (54CM)Color LCD Monitor CCL256I2(CL21256)Summary page 1…c. 892.2050 Picture Archiving and Communication System) Predicate Device: 21.3 inch (54 cm) Cotl or LCD Monitor CCL25 6i2 (CL21256) (K113 136) Device Description: CCL2S8i2 (CL21258) is a 21.3-inch (54 cm) Color LCD monitor whose display… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 (54 cm) Color 2M pixel LCD Monitor CCL258i2 (CL21258) 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.
https://510kreport.com/device/K133181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133181: 21.3 Inch (54 CM) Color LCD Monitor CCL258I2 (CL21258).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133181
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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