510(k) · Cleared
ClearedPentax Epk-I5020 Video Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jun 22, 2012 as substantially equivalent to K102466 (Fujinon, Inc., 2011) after a 175-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.
- Decided
- Jun 22, 2012
- Review
- 175 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944620 (1995). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995 · Recalled
- 1 generation backK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- This deviceK113873 Pentax Epk-I5020 Video ProcessorPentax of America, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK122470 Pentax Epk-I5010 Video ProcessorPentax Medical · 2013
- Descendant · 2 generations on · 3 of its ownK150618 PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK231249 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK190805 PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video…Pentax of America, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK251127 PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc. · 2025 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122470Pentax Epk-I5010 Video ProcessorPentax Medical · 2013 · cites it directly6descendants
- K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc. · 2015 · 2 generations on3descendants
- K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc. · 2023 · 3 generations on1descendant
- K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc. · 2019 · 2 generations on1descendant
- K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | 2 |
| −1 | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| 0 (this device) | K113873 | Pentax Epk-I5020 Video Processor | Pentax of America, Inc. | 2012 | — |
| +1 | K122470 | Pentax Epk-I5010 Video Processor | Pentax Medical | 2013 | — |
| +2 | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015 | — |
| +3 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2023 | 4 |
| +2 | K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2019 | — |
| +4 | K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K102466 | Fujinon Epx-4440HD Digital Video ProcessorSummary page 1…ss: Class 11 Product Code: PET and GCT Predicate Device: Fujinon EPX-4440HD Digital Processor and Light Source (K1 02466 dated May 25,,2011) Device Description: The EPK-i5020 Video Processor is consists of light source with 300 W Xenon Lamp to prov… | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122470 | Pentax Epk-I5010 Video Processor | 2013 | 6 |
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 17 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122470 (Pentax Medical, 2013) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K102466.
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. 2012, 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 EPK-15020 Video Processor is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to be used with PENTAX Video Endoscopes to provide illumination, control air pump to supply air through the video endloscope to help clear visualization, convert data from video endoscope into standard video output for visualization via video monitor, and interfacing with external peripheral devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113873: Pentax Epk-I5020 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/K113873
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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