510(k) · Cleared
ClearedPusen Eview Medical Video Endoscope Image Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuhai Pusen Medical Technology Co., Ltd. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Mar 29, 2019 as substantially equivalent to K131953 (KARL STORZ Endoscopy-America, Inc., 2013) after a 16-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Mar 29, 2019
- Review
- 16 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944620 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995 · Recalled
- 2 generations backK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- 1 generation backK131953 IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- This deviceK190648 Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK251734 ProVee Video Processing Unit (PV-003)Proverum Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K251734ProVee Video Processing Unit (PV-003)Proverum Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | 2 |
| −2 | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| −1 | K131953 | IMAGE1 Spies | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| 0 (this device) | K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | 2019 | — |
| +1 | K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K131953 | IMAGE1 SpiesSummary page 4…cation: 21 CFR 876.1500 Endoscope and accessories. Class II Product Code: FET 3. Predicate Device: Trade name: Image 1 SPIES Premarket Notification: K131953 4. Device description: 5-1… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251734 | ProVee Video Processing Unit (PV-003) | 2025 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K251734 (Proverum Limited, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K131953.
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. 2019, 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?
This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190648: Pusen Eview Medical Video Endoscope Image Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190648
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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