510(k) · Cleared
Cleared6MP Color LCD Monitor CL-S600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jvckenwood Corporation · PGY Display, Diagnostic Radiology
Cleared on Dec 16, 2021 as substantially equivalent to K140214 (Jvckenwood Corporation, 2014) after a 90-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Dec 16, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K032555 (2004). No later device cites it as a predicate yet.
- Root · 8 generations backK032555 3M Color Medical Flat Panel Display, CCL316Totoku Electric Co., Ltd. · 2004
- 7 generations backK043430 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd. · 2005
- 6 generations backK050619 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I &…Totoku Electric Co., Ltd. · 2005
- 5 generations backK072065 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007
- 4 generations backK081056 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008
- 3 generations backK112604 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
- 2 generations backK133185 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Jvckenwood Corporation · 2013
- 1 generation backK140214 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 2014
- This deviceK212985 6MP Color LCD Monitor CL-S600Jvckenwood Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K032555 | 3M Color Medical Flat Panel Display, CCL316 | Totoku Electric Co., Ltd. | 2004 | — |
| −7 | K043430 | 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −6 | K050619 | 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −5 | K072065 | 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2) | Totoku Electric Co., Ltd. | 2007 | — |
| −4 | K081056 | 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A) | Totoku Electric Co., Ltd. | 2008 | — |
| −3 | K112604 | 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356) | Totoku Electric Co., Ltd. | 2011 | — |
| −2 | K133185 | 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358) | Jvckenwood Corporation | 2013 | — |
| −1 | K140214 | 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6) | Jvckenwood Corporation | 2014 | — |
| 0 (this device) | K212985 | 6MP Color LCD Monitor CL-S600 | Jvckenwood Corporation | 2021 | — |
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 PGY? 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 PGY device
- #1 K261213 Medical Monitor (40HT513D)score 13.9 · 9 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 |
|---|---|---|---|
| * | K140214 | 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Summary page 4…Medical Image Management and Processing System Predicate Device: 30 inch (76.8cm) Color LCD Monitor CCL650i2 (CL30650/ K140214) Device Description: 30 inch Color LCD Monitor 3280 x 2080 (landscape) ■… | 2014 |
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 17 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All PGY devicesPGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PGY
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGY
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGY
No recall names PGY since 2007.
Adverse event reports per year · PGY
1in 2017
MAUDE reports naming product code PGY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 14 | 24 | 0 | 0 |
| 2015 | 16 | 31 | 0 | 0 |
| 2016 | 18 | 27 | 0 | 0 |
| 2017 | 11 | 30 | 0 | 1 |
| 2018 | 5 | 28 | 0 | 0 |
| 2019 | 11 | 58 | 0 | 0 |
| 2020 | 12 | 61 | 0 | 0 |
| 2021 | 7 | 77 | 0 | 0 |
| 2022 | 10 | 60 | 0 | 0 |
| 2023 | 17 | 60 | 0 | 0 |
| 2024 | 10 | 53 | 0 | 0 |
| 2025 | 3 | 59 | 0 | 0 |
| 2026 | 4 | 48 | 0 | — |
What is it indicated for?
CL-S600 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212985: 6MP Color LCD Monitor CL-S600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212985
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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