510(k) · Cleared
ClearedSony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sony Electronics, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 29, 2015 as substantially equivalent to K113203 (Sony Electronics, Inc., 2012) after a 166-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it.
- Decided
- Jul 29, 2015
- Review
- 166 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. 9 later devices descend from it, 2 citing it directly.
- 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 deviceK150377 Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony…Sony Electronics, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK220069 4K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. · 2022 · Recalled
- Descendant · 2 generations on · 5 of its ownK231066 CuratOR EX3242-FDEizo Corporation · 2023
- Descendant · 3 generations on · 3 of its ownK241402 Medical Monitor (32HR734S)Lg Electronics.Inc · 2024
- Descendant · 4 generations on · 1 of its ownK251209 Medical Monitor (32HS710S)Lg Electronics.Inc · 2025
- Descendant · 3 generations on · 0 of its ownK262397 CuratOR EX2742Eizo Corporation · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K2200694K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. · 2022 · cites it directly7descendants
- K231066CuratOR EX3242-FDEizo Corporation · 2023 · 2 generations on5descendants
- K241402Medical Monitor (32HR734S)Lg Electronics.Inc · 2024 · 3 generations on3descendants
- K251209Medical Monitor (32HS710S)Lg Electronics.Inc · 2025 · 4 generations on1descendant
- K262397CuratOR EX2742Eizo Corporation · 2026 · 3 generations on0descendants
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) | K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD… | Sony Electronics, Inc. | 2015 | — |
| +1 | K220069 | 4K UHD LCD Monitor OEV321UH | Olympus Medical Systems Corp. | 2022 | 1 |
| +2 | K231066 | CuratOR EX3242-FD | Eizo Corporation | 2023 | — |
| +3 | K241402 | Medical Monitor (32HR734S) | Lg Electronics.Inc | 2024 | — |
| +4 | K251209 | Medical Monitor (32HS710S) | Lg Electronics.Inc | 2025 | — |
| +3 | K262397 | CuratOR EX2742 | Eizo Corporation | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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…X550MD and LMD-X550NB 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K113203 Applicant: Sony Electronics Inc. Device Name: SONY LMD-2451MT LCD MONITOR Regulation Number:… | 2012 |
What descends from it? (9)
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)
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 20 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K220069 (Olympus Medical Systems Corp., 2022) has gone furthest, with 7 descendants of its own.
- 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. 2015, 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 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 LCD Monitor is a wide-screen, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150377: Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150377
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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