510(k) · Cleared
ClearedEpx-4440HD Digital Video Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Cleared on Aug 22, 2014 as substantially equivalent to K102466 (Fujinon, Inc., 2011) and 1 other predicate after a 212-day review. Its family tree reaches back 8 generations to 1993. 3 of the 47 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 212 days
- Class
- Class II
- Product code
- PEA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931154 (1993). 30 ancestors in all, the oldest K843084 (1985). 16 later devices descend from it, 4 citing it directly. 3 of the 47 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 4 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 3 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 2 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 1 generation backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- This deviceK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- Descendant · cites it directly · 8 of its ownK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- Descendant · 3 generations on · 3 of its ownK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
- Descendant · 4 generations on · 1 of its ownK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017 · cites it directly12descendants
- K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017 · cites it directly8descendants
- K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020 · 2 generations on6descendants
- K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021 · 3 generations on3descendants
- K250268HyperSnap Surgical System (HSS)Hypervision Surgical · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −4 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −3 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −2 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −1 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| 0 (this device) | K140149 | Epx-4440HD Digital Video Processor | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| +1 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| +1 | K162836 | FUJIFILM Surgical System | Fujifilm New Development U.S.A., Inc. | 2017 | — |
| +2 | K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020 | — |
| +3 | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021 | — |
| +4 | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | 2025 | — |
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 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 PEA device
- #1 K251127 PENTAX Medical Video Processor (EPK-i8020c)score 10.7 · 12 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K102466 | Fujinon Epx-4440HD Digital Video ProcessorSummary page 5…Arc 21 CFR 876.1500 GCT Predicate Devices: Fujifilm Medical Systems U.S.A., Inc.’s EPX-4440HD Digital Video Processor and Light Source (K102466) Olympus Medical Systems Corp.’s EVIS EXERA II 180 System (K100584)… | 2011 |
| * | K100584 | Evis Exeraii 180 SystemSummary page 5…m Medical Systems U.S.A., Inc.’s EPX-4440HD Digital Video Processor and Light Source (K102466) Olympus Medical Systems Corp.’s EVIS EXERA II 180 System (K100584) K140149… | 2010 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 17 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K163675 (Fujifilm Medical System U.S.A., Inc., 2017) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K102466.
How does its category compare?
All PEA devicesPEA Endoscope, Accessories, Image Post-Processing For Color Enhancement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PEA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEA
Too few PEA 510(k)s in any year since 2007 to give a median.
Recalls per year · PEA
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEA
60in 2025
MAUDE reports naming product code PEA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 38 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 201 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 103 |
| 2025 | 1 | — | 0 | 60 |
| 2026 | 0 | — | 1 | — |
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 a Fujinon/Fujifilm medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140149: 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/K140149
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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