510(k) · Cleared
Cleared30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)
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 Feb 19, 2014 as substantially equivalent to K133185 (Jvckenwood Corporation, 2013) after a 22-day review. Its family tree reaches back 7 generations to 2004. 1 later device descends from it.
- Decided
- Feb 19, 2014
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K032555 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK032555 3M Color Medical Flat Panel Display, CCL316Totoku Electric Co., Ltd. · 2004
- 6 generations backK043430 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd. · 2005
- 5 generations backK050619 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I &…Totoku Electric Co., Ltd. · 2005
- 4 generations backK072065 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007
- 3 generations backK081056 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008
- 2 generations backK112604 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
- 1 generation backK133185 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Jvckenwood Corporation · 2013
- This deviceK140214 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 2014
- Descendant · cites it directly · 0 of its ownK212985 6MP Color LCD Monitor CL-S600Jvckenwood Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K2129856MP Color LCD Monitor CL-S600Jvckenwood Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K032555 | 3M Color Medical Flat Panel Display, CCL316 | Totoku Electric Co., Ltd. | 2004 | — |
| −6 | K043430 | 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −5 | K050619 | 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −4 | K072065 | 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2) | Totoku Electric Co., Ltd. | 2007 | — |
| −3 | K081056 | 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A) | Totoku Electric Co., Ltd. | 2008 | — |
| −2 | K112604 | 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356) | Totoku Electric Co., Ltd. | 2011 | — |
| −1 | K133185 | 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358) | Jvckenwood Corporation | 2013 | — |
| 0 (this device) | K140214 | 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6) | Jvckenwood Corporation | 2014 | — |
| +1 | K212985 | 6MP Color LCD Monitor CL-S600 | Jvckenwood Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133185 | 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Summary page 1…icture Archiving and Communication System) Predicate Device: 21.3 inch (54 cm) Color LCD Monitor CCL35Si2 (Ct21358) (K133 185) Device Description: CCL65Oi2 (CL30650, MD302C6) is a 6M 30.0-inch Color LCD m… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212985 | 6MP Color LCD Monitor CL-S600 | 2021 | 0 |
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 11 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K212985 (Jvckenwood Corporation, 2021) has gone furthest, with 0 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. 2014, 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?
6M pixel 30.0 inch Color LCD Monitor CCL-6S0i2 (CI.30650, MD302C6) is intended tn be used indisplaying and viewing medical images for diagnosis by trained Medical practitioners. It is nol meant to be used in digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140214: 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140214
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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