510(k) · Cleared
Recalled · 2026PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
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 Nov 8, 2019 as substantially equivalent to K150618 (Pentax of America, Inc., 2015) and 2 other predicates after a 179-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. It has been recalled once.
- Decided
- Nov 8, 2019
- Review
- 179 days
- Class
- Class II
- Product code
- PEA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K931154 (1993). 38 ancestors in all, the oldest K790071 (1979). No later device cites it as a predicate yet. 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 deviceK191282 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with…Pentax of America, Inc. · 2019
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 deviceK191282 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with…Pentax of America, Inc. · 2019
Class I recalls in this family
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) | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | Pentax of America, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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
- #2 Held for the reportin the report
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 5…with GI Family of Endoscopes 510(k) Summary III. PREDICATE DEVICES The predicate device for this submission, PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618), is virtually identical to the subject device. It’s predicate, the PENTAX EPK- i5010 Video Processor was the predicate for the E… | 2015 |
| * | K122470 | Pentax Epk-I5010 Video ProcessorSummary page 5…618), is virtually identical to the subject device. It’s predicate, the PENTAX EPK- i5010 Video Processor was the predicate for the EPK-i7010 submission, cleared through K122470, and it will be bundled in this submission. The subject devices differ from the predicate due to the replacement of accessory PEN… | 2013 |
| * | K093665 | Endo SmartcapSummary page 6…PENTAX Medical DispoCap 100160P Air (MEDIVATORS Endo (DispoCap Air SmartCap Tubing - K093665) Tubing) Table 2: List of Compatible Devices Compatible… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2026 | Not classified | Z-0310-2027 | Unknown/Undetermined by firm | Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. |
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 26 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 20 of the 38 ancestors have a recall of any class; 3 have a Class I recall.
- 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. 2019, 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 EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to…
Read the full statement (167 words)
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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 EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX EPK-i5010 includes PENTAX i-Scan™, a digital post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191282: PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191282
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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