510(k) · Cleared
Cleared4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kms Medical Technology Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 30, 2026 as substantially equivalent to K180583 (Richard Wolf Medical Instruments Corporation, 2018) after a 233-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Apr 30, 2026
- Review
- 233 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950862 (1995). 15 ancestors in all, the oldest K942817 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 6 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 5 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 4 generations backK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
- 3 generations backK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- 2 generations backK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
- 1 generation backK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
- This deviceK252858 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −6 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −5 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −4 | K063457 | Truehd (1080P) Digital Camera System | Conmed Linvatec | 2006 | — |
| −3 | K080977 | 3 CCD Endocam 5550 | Richard Wolf Medical Instruments Corp. | 2008 | — |
| −2 | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525 | Richard Wolf Medical Instruments Corp. | 2013 | — |
| −1 | K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corporation | 2018 | — |
| 0 (this device) | K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K180583 | Logic 4K Camera Controller, Logic 4K Camera HeadSummary page 5…: General & Plastic Surgery 3. Predicate Device Predicate Device 510(k) Number K180583 Trade Name LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD Manufacture Richard Wolf Medic… | 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 31 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 2 other devices also cite its predicate K180583.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Endoscopy Camera System, when used in conjunction with optical endoscope, cold light source and monitor, is intended to convert the optical signals captured by the endoscope into electronic signals and transmits them to the monitor for imaging, and can be used for both diagnostic and therapeutic interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252858: 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252858
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026