510(k) Report

510(k) · Cleared

Cleared

Medical Monitor (32HS710S)

K251209510(k) TraditionalCleared Jun 12, 202555-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lg Electronics.Inc · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 12, 2025 as substantially equivalent to K241402 (Lg Electronics.Inc, 2024) after a 55-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.

Decided
Jun 12, 2025
Review
55 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K943305 (1995). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 7 generations backK943305 Olympus 3D Surgical Endoscopy SystemOlympus America, Inc. · 1995
  2. 6 generations backK102379 LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation · 2011
  3. 5 generations backK113203 Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012
  4. 4 generations backK150377 Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony…Sony Electronics, Inc. · 2015
  5. 3 generations backK220069 4K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. · 2022 · Recalled
  6. 2 generations backK231066 CuratOR EX3242-FDEizo Corporation · 2023
  7. 1 generation backK241402 Medical Monitor (32HR734S)Lg Electronics.Inc · 2024
  8. This deviceK251209 Medical Monitor (32HS710S)Lg Electronics.Inc · 2025
  9. Descendant · cites it directly · 0 of its ownK261614 LED LCD Monitor (OEV-271H)Lg Electronics.Inc · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K943305Olympus 3D Surgical Endoscopy SystemOlympus America, Inc.1995—
−6K102379LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation2011—
−5K113203Sony LMD-2451MT LCD MonitorSony Electronics, Inc.2012—
−4K150377Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD…Sony Electronics, Inc.2015—
−3K2200694K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp.20221
−2K231066CuratOR EX3242-FDEizo Corporation2023—
−1K241402Medical Monitor (32HR734S)Lg Electronics.Inc2024—
0 (this device)K251209Medical Monitor (32HS710S)Lg Electronics.Inc2025—
+1K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
200810
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K251209, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K241402Medical Monitor (32HR734S)
Summary page 5
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K241402 32HR734S GCJ Device Descri…
Lg Electronics.Inc2024—

Also cleared against K241402: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc20260

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 30 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K261614 (Lg Electronics.Inc, 2026) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K241402.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K251209: Medical Monitor (32HS710S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251209

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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