510(k) · Cleared
Recalled · Class II · 2025PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Cleared on Jul 28, 2023 as substantially equivalent to K150618 (Pentax of America, Inc., 2015) and 2 other predicates after an 88-day review. Its family tree reaches back 11 generations to 1993. 3 of the 39 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jul 28, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- PEA
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 11 generations to K931154 (1993). 37 ancestors in all, the oldest K843084 (1985). 1 later device descends from it, 1 citing it directly. 3 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 2 generations backK122470 Pentax Epk-I5010 Video ProcessorPentax Medical · 2013
- 1 generation backK150618 PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc. · 2015
- This deviceK231249 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251127 PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc. · 2025 · Recalled
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 7 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 6 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 5 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 4 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 3 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 2 generations backK122470 Pentax Epk-I5010 Video ProcessorPentax Medical · 2013
- 1 generation backK150618 PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc. · 2015
- This deviceK231249 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −7 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −6 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −5 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −4 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −3 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −2 | K122470 | Pentax Epk-I5010 Video Processor | Pentax Medical | 2013 | — |
| −1 | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015 | — |
| 0 (this device) | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2023 | — |
| +1 | K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | 2025 | 1 |
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 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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.
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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI FamilySummary page 6…Predicate Device PENTAX Medical Video Processor PENTAX Medical Video Processor EPK-i8020c EPK-i7010 (K150618) PENTAX Medical Video Upper GI Scope PENTAX Video Upper G.I. Scope EG29-i20c EG29-i10 (K131… | 2015 |
| * | K131902 | Pentax Video Upper G.I. Scopes (EG Family)Summary page 6…EPK-i7010 (K150618) PENTAX Medical Video Upper GI Scope PENTAX Video Upper G.I. Scope EG29-i20c EG29-i10 (K131902) PENTAX Medical Video Colonoscope PENTAX Video Colonoscope EC38-i20cL EC38-i1… | 2014 |
| * | K131855 | Pentax Video Colonoscopes (EC Family)Summary page 6…EG29-i10 (K131902) PENTAX Medical Video Colonoscope PENTAX Video Colonoscope EC38-i20cL EC38-i10L (K131855) 4. REFERENCE DEVICE A previously cleared PENTAX Medical Video Scopes have been chosen as a reference device:… | 2014 |
| † | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | 2019 |
| † | K180292 | PENTAX Video Upper G.I. Scope EG34-i10 | 2018 |
| † | K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | 2021 |
| † | K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | 2018 |
| † | K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | 2019 |
| † | K202365 | Pentax Medical Video Duodenoscope ED32-i10 | 2021 |
| † | K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope… | 2019 |
| † | K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI… | 2020 |
| † | K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound… | 2020 |
| † | K131780 | Evis Exera Iii Video System | 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 |
|---|---|---|---|
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | 2025 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2025 | Class II | Z-2329-2025 | Device Design | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the… |
| Jan 29, 2025 | Class II | Z-1238-2025 | Device Design | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light… |
| Jan 29, 2025 | Class II | Z-1237-2025 | Device Design | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light… |
| Jan 29, 2025 | Class II | Z-1236-2025 | Device Design | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light… |
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 30 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 20 of the 37 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K251127 (Pentax of America, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150618.
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. 2023, 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 PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are…
Read the full statement (235 words)
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.
The PENTAX Medical Video Upper GI Scope EG29-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.
The PENTAX Medical Video Colonoscope EC38-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.
This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231249: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231249
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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