510(k) · Cleared
ClearedFujinon Epx-4440HD Digital Video Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on May 25, 2011 as substantially equivalent to K944620 (Marks & Murase, 1995) after a 268-day review. Its family tree reaches back 1 generation to 1995. 37 later devices descend from it.
- Decided
- May 25, 2011
- Review
- 268 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944620 (1995). 37 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995 · Recalled
- This deviceK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- Descendant · cites it directly · 16 of its ownK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
- Descendant · 2 generations on · 12 of its ownK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- Descendant · cites it directly · 10 of its ownK131953 IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
- Descendant · cites it directly · 7 of its ownK113873 Pentax Epk-I5020 Video ProcessorPentax of America, Inc. · 2012
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014 · cites it directly16descendants
- K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017 · 2 generations on12descendants
- K131953IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · cites it directly10descendants
- K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017 · 2 generations on8descendants
- K113873Pentax Epk-I5020 Video ProcessorPentax of America, Inc. · 2012 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | 2 |
| 0 (this device) | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| +1 | K140149 | Epx-4440HD Digital Video Processor | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| +2 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| +1 | K131953 | IMAGE1 Spies | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +2 | K162836 | FUJIFILM Surgical System | Fujifilm New Development U.S.A., Inc. | 2017 | — |
| +1 | K113873 | Pentax Epk-I5020 Video Processor | Pentax of America, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K944620 | Series 400 Gastroenterology SystemSummary page 1…Code FET) and Light Source, Endloscope, Xenon Arc (Product Code GCT) - Both product codes are covered under 21 CFR 876.1500 - Predicate device(s): Fujinon 400 Series (K944620) Device description: This system is intended to be used in conjunction with Fujinon endoscopes to provide illumina… | 1995 |
What descends from it? (37)
See all 374 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?
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. 2011, 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?
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices. The XL-4450 light source is used for endoscopic observation…
Read the full statement (132 words)
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices.
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102466: Fujinon Epx-4440HD Digital Video Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102466
Report an extraction error
Are you the manufacturer?
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