510(k) · Cleared
ClearedEndoscopic Camera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Sophway Technology Co., Ltd. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jul 1, 2025 as substantially equivalent to K160044 (Karl Storz Endoscopy America, Inc., 2016) after a 158-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jul 1, 2025
- Review
- 158 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944620 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995 · Recalled
- 3 generations backK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- 2 generations backK131953 IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 1 generation backK160044 Image1 SPIES SystemKarl Storz Endoscopy America, Inc. · 2016
- This deviceK250204 Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | 2 |
| −3 | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| −2 | K131953 | IMAGE1 Spies | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −1 | K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016 | — |
| 0 (this device) | K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 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 |
|---|---|---|---|
| * | K160044 | Image1 SPIES SystemSummary page 6…hrough software. 4. Technology K250204 Page 2 / 2 Predicate Device: Product Code FET, Image1 SPIES System, cleared under K160044 The predicate and subject devices are both camera systems used for the visualization and documentation of endoscopic and microsc… | 2016 |
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 30 years and passes through 5 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K160044.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250204 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250204: Endoscopic Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250204
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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