510(k) · Cleared
ClearedPENTAX Medical EPK-i7010 Video Processor 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 24, 2015 as substantially equivalent to K122470 (Pentax Medical, 2013) after a 259-day review. Its family tree reaches back 10 generations to 1993. 3 of the 38 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Nov 24, 2015
- Review
- 259 days
- Class
- Class II
- Product code
- PEA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931154 (1993). 34 ancestors in all, the oldest K843084 (1985). 3 later devices descend from it, 2 citing it directly. 3 of the 38 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 backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 1 generation backK122470 Pentax Epk-I5010 Video ProcessorPentax Medical · 2013
- This deviceK150618 PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK231249 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK251127 PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK191282 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with…Pentax of America, Inc. · 2019 · Recalled
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 backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 1 generation backK122470 Pentax Epk-I5010 Video ProcessorPentax Medical · 2013
- This deviceK150618 PENTAX Medical EPK-i7010 Video Processor with GI FamilyPentax of America, Inc. · 2015
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc. · 2023 · cites it directly1descendant
- K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc. · 2025 · 2 generations on0descendants
- K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc. · 2019 · cites it directly0descendants
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 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −1 | K122470 | Pentax Epk-I5010 Video Processor | Pentax Medical | 2013 | — |
| 0 (this device) | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015 | — |
| +1 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2023 | 4 |
| +2 | K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | 2025 | 1 |
| +1 | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | Pentax of America, Inc. | 2019 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K122470 | Pentax Epk-I5010 Video ProcessorSummary page 4…876.1500) Regulatory Class: Class II Product Code: PEA III. PREDICATE DEVICE The PENTAX Medical EPK-i5010 Video Processor (K122470; dated April 22, 2013) is the primary predicate for this submission. This predicate device has not been subject to a design-relat… | 2013 |
| † | K112680 | Evis Exera Iii Video System | 2012 |
What descends from it? (3)
2 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 · 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 22 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 18 of the 34 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K231249 (Pentax of America, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122470.
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. 2015, 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 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 video gastrointestinal endoscopes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150618: PENTAX Medical EPK-i7010 Video Processor 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/K150618
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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