510(k) · Cleared
Recalled · Class II · 2021Pentax Video Colonoscopes (EC Family)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical Company · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Apr 9, 2014 as substantially equivalent to K001241 (The Olympus Optical Co., 2000) and 1 other predicate after a 292-day review. Its family tree reaches back 8 generations to 1993. 3 of the 42 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 9, 2014
- Review
- 292 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931154 (1993). 28 ancestors in all, the oldest K843084 (1985). 13 later devices descend from it, 8 citing it directly. 3 of the 42 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 deviceK131855 Pentax Video Colonoscopes (EC Family)Pentax Medical Company · 2014
- Descendant · cites it directly · 3 of its ownK181084 PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK192588 G-EYE SystemSmart Medical Systems, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK231249 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK202469 G-EYE SystemSmart Medical Systems, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK190805 PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video…Pentax of America, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc. · 2019 · cites it directly3descendants
- K192588G-EYE SystemSmart Medical Systems, Ltd. · 2020 · 2 generations on2descendants
- K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc. · 2023 · cites it directly1descendant
- K202469G-EYE SystemSmart Medical Systems, Ltd. · 2020 · 3 generations on1descendant
- K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc. · 2019 · cites it directly1descendant
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) | K131855 | Pentax Video Colonoscopes (EC Family) | Pentax Medical Company | 2014 | — |
| +1 | K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2019 | 2 |
| +2 | K192588 | G-EYE System | Smart Medical Systems, Ltd. | 2020 | — |
| +1 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2023 | 4 |
| +3 | K202469 | G-EYE System | Smart Medical Systems, Ltd. | 2020 | — |
| +1 | K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope… | Pentax of America, Inc. | 2019 | — |
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 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 1…egulatory Class: Class 11 Product Code: FOE Predicate Device: OLYMPUS Colonovideoscope CF TYPE Q16OAL (K00 1241; dated May 9 2000) OLYMPUS Colo novid eoscope CIF TYPE Q18OAL (K1 00584… | 2000 |
| * | K100584 | Evis Exeraii 180 SystemSummary page 1…PE Q16OAL (K00 1241; dated May 9 2000) OLYMPUS Colo novid eoscope CIF TYPE Q18OAL (K1 00584; dated Jul 2 2010) Regulation Number: 21 CFR Part 876.1500 Regulation Name: Endoscope and accessories Regu… | 2010 |
What descends from it? (13)
See all 138 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181084 | PENTAX Video Colonoscopes (EC Family) | 2019 | 3 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope… | 2023 | 1 |
| K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope… | 2019 | 1 |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video… | 2025 | 0 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | 2025 | 0 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope… | 2024 | 0 |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC… | 2021 | 0 |
| K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | 2018 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2021 | Class II | Z-2448-2021 | Device Design | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families |
| Jul 14, 2021 | Class II | Z-2449-2021 | Device Design | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families |
| Jan 3, 2020 | Class II | Z-1268-2020 | Mixed-up of materials/components | Distributed in the USA without an approved 510K |
| Jan 3, 2020 | Class II | Z-1267-2020 | Mixed-up of materials/components | Distributed in the USA without an approved 510K |
| Aug 15, 2016 | Class II | Z-0636-2017 | Other | Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were… |
| Apr 6, 2016 | Class II | Z-2068-2016 | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
The 5 latest of 6 recalls; the web page lists all.
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.
- 16 of the 28 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K181084 (Pentax of America, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 14 other devices also cite its predicate K001241.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131855: Pentax Video Colonoscopes (EC Family).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131855
Report an extraction error
Are you the manufacturer?
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