510(k) · Cleared
Cleared8MP Color LCD Monitor CL-R813
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 21, 2022 as substantially equivalent to K182539 (Jvckenwood Corporation, 2018) after a 90-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Dec 21, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- PGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000293 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 6 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 5 generations backK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
- 4 generations backK092728 20.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd. · 2010
- 3 generations backK151134 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation · 2015
- 2 generations backK161895 2MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation · 2016
- 1 generation backK182539 2MP Color LCD Monitor CL-R211Jvckenwood Corporation · 2018
- This deviceK222864 8MP Color LCD Monitor CL-R813Jvckenwood Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −6 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −5 | K021738 | Flat Panel Displays, ME Series & CCL Series | Totoku Electric Co., Ltd. | 2002 | — |
| −4 | K092728 | 20.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A) | Totoku Electric Co., Ltd. | 2010 | — |
| −3 | K151134 | 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) | Jvckenwood Corporation | 2015 | — |
| −2 | K161895 | 2MP Color LCD Monitor CCL214 (CL21214) | Jvckenwood Corporation | 2016 | — |
| −1 | K182539 | 2MP Color LCD Monitor CL-R211 | Jvckenwood Corporation | 2018 | — |
| 0 (this device) | K222864 | 8MP Color LCD Monitor CL-R813 | Jvckenwood Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K182539 | 2MP Color LCD Monitor CL-R211Summary page 4…II Product Code PGY III. Predicate Device Name of Device: 21.3 inch (54.0cm) Color LCD Monitor CL-R211 (K182539) Common or Usual Name: Display, diagnostic radiology Classification Name: Medical Image Manageme… | 2018 |
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 22 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 7 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. 2022, 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-R813 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/K222864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222864: 8MP Color LCD Monitor CL-R813.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222864
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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