510(k) · Cleared
ClearedE240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Jusha Display Technology Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 31, 2019 as substantially equivalent to K113203 (Sony Electronics, Inc., 2012) after a 60-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 31, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943305 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943305 Olympus 3D Surgical Endoscopy SystemOlympus America, Inc. · 1995
- 2 generations backK102379 LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation · 2011
- 1 generation backK113203 Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012
- This deviceK190831 E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor…Nanjing Jusha Display Technology Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943305 | Olympus 3D Surgical Endoscopy System | Olympus America, Inc. | 1995 | — |
| −2 | K102379 | LTF-Y0009; Maj-YOO41; Xoev-3D1 | Olympus Medical Systems Corporation | 2011 | — |
| −1 | K113203 | Sony LMD-2451MT LCD Monitor | Sony Electronics, Inc. | 2012 | — |
| 0 (this device) | K190831 | E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A… | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2008 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K113203 | Sony LMD-2451MT LCD MonitorSummary page 4…Common/Usual Name: LCD Monitor Classification Name: Endoscope and Accessories Product Code: GCJ Predicate Device(s): Sony LMD-2451MT LCD Monitor, K 113203 Device Description: The E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJ… | 2012 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K113203.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190831 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190831: E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190831
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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