510(k) · Cleared
Recalled · Class II · 20264K UHD LCD Monitor OEV321UH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 9, 2022 as substantially equivalent to K150377 (Sony Electronics, Inc., 2015) after a 58-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2022
- Review
- 58 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943305 (1995). 7 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943305 Olympus 3D Surgical Endoscopy SystemOlympus America, Inc. · 1995
- 3 generations backK102379 LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation · 2011
- 2 generations backK113203 Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012
- 1 generation backK150377 Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony…Sony Electronics, Inc. · 2015
- This deviceK220069 4K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. · 2022
- Descendant · cites it directly · 5 of its ownK231066 CuratOR EX3242-FDEizo Corporation · 2023
- Descendant · 2 generations on · 3 of its ownK241402 Medical Monitor (32HR734S)Lg Electronics.Inc · 2024
- Descendant · 3 generations on · 1 of its ownK251209 Medical Monitor (32HS710S)Lg Electronics.Inc · 2025
- Descendant · 2 generations on · 0 of its ownK262397 CuratOR EX2742Eizo Corporation · 2026
- Descendant · 4 generations on · 0 of its ownK261614 LED LCD Monitor (OEV-271H)Lg Electronics.Inc · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231066CuratOR EX3242-FDEizo Corporation · 2023 · cites it directly5descendants
- K241402Medical Monitor (32HR734S)Lg Electronics.Inc · 2024 · 2 generations on3descendants
- K251209Medical Monitor (32HS710S)Lg Electronics.Inc · 2025 · 3 generations on1descendant
- K262397CuratOR EX2742Eizo Corporation · 2026 · 2 generations on0descendants
- K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943305 | Olympus 3D Surgical Endoscopy System | Olympus America, Inc. | 1995 | — |
| −3 | K102379 | LTF-Y0009; Maj-YOO41; Xoev-3D1 | Olympus Medical Systems Corporation | 2011 | — |
| −2 | K113203 | Sony LMD-2451MT LCD Monitor | Sony Electronics, Inc. | 2012 | — |
| −1 | K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD… | Sony Electronics, Inc. | 2015 | — |
| 0 (this device) | K220069 | 4K UHD LCD Monitor OEV321UH | Olympus Medical Systems Corp. | 2022 | — |
| +1 | K231066 | CuratOR EX3242-FD | Eizo Corporation | 2023 | — |
| +2 | K241402 | Medical Monitor (32HR734S) | Lg Electronics.Inc | 2024 | — |
| +3 | K251209 | Medical Monitor (32HS710S) | Lg Electronics.Inc | 2025 | — |
| +2 | K262397 | CuratOR EX2742 | Eizo Corporation | 2026 | — |
| +4 | K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor…Summary page 5…ame 510(k) Submitter 510(k) No. Sony LMD-X310S LCD Monitor Sony Electronics Incorporated K150377 Indications for Use The 4K UHD LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic/lapar… | 2015 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2026 | Class II | Z-2761-2026 | Nonconforming Material/Component | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K231066 (Eizo Corporation, 2023) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K150377.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 4K UHD LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The 4K UHD LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during endoscopic/laparoscopic 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/K220069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220069: 4K UHD LCD Monitor OEV321UH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220069
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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