510(k) · Cleared
ClearedEPX-4440FN Digital Video Processor with Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm New Development U.S.A., Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on May 24, 2018 as substantially equivalent to K162836 (Fujifilm New Development U.S.A., Inc., 2017) and 1 other predicate after a 98-day review. Its family tree reaches back 10 generations to 1993. 3 of the 34 devices in its family, counting itself, have a Class I recall.
- Decided
- May 24, 2018
- Review
- 98 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931154 (1993). 33 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
- 1 generation backK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
- This deviceK180414 EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc. · 2018
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 6 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 5 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 4 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
- 1 generation backK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
- This deviceK180414 EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., Inc. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −6 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −5 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −2 | K140149 | Epx-4440HD Digital Video Processor | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −1 | K162836 | FUJIFILM Surgical System | Fujifilm New Development U.S.A., Inc. | 2017 | — |
| 0 (this device) | K180414 | EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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.
3 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K162836 | FUJIFILM Surgical SystemSummary page 4…Endoscope and Accessories; 21 C.F.R. 876.1500 Class II Product Code: FET, GCT and PEA Predicate Devices FUJIFILM New Development U.S.A., Inc. FUJIFILM Surgical System (K162836) FUJIFILM Corp. EPX-4440HD Digital Video Processor with FICE and Light Source (K140149) Device Description The EPX-4440FN Digita… | 2017 |
| * | K140149 | Epx-4440HD Digital Video ProcessorSummary page 4…Predicate Devices FUJIFILM New Development U.S.A., Inc. FUJIFILM Surgical System (K162836) FUJIFILM Corp. EPX-4440HD Digital Video Processor with FICE and Light Source (K140149) Device Description The EPX-4440FN Digital Video Processor with Light Source is comprised of: o VP-4440FN Video Proce… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 17 of the 33 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K162836.
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. 2018, 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 EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or…
Read the full statement (110 words)
The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devise. FICE (Flexible spectral-Imaging Color Enhancement) is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathologic sampling as a means of diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180414: EPX-4440FN Digital Video Processor with Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180414
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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