510(k) · Cleared
Recalled · Class II · 2024Evis Exera Iii Video System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Aug 29, 2013 as substantially equivalent to K112680 (Olympus Medical Systems Corporation, 2012) after a 73-day review. Its family tree reaches back 9 generations to 1993. 4 of the 38 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 29, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931154 (1993). 30 ancestors in all, the oldest K843084 (1985). 7 later devices descend from it, 4 citing it directly. 4 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- This deviceK131780 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013
- Descendant · cites it directly · 2 of its ownK222584 Evis X1 Video System Center Olympus CV-1500, Colonovideoscope…Olympus Medical Systems Corporation · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK222861 EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope…Olympus Medical Systems Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK250862 Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii…Olympus Medical Systems Corp. · 2025 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK243261 FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model…Fujifilm Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK250432 Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI)…Olympus Medical Systems Corporation · 2025
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 5 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 4 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- This deviceK131780 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K222584Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Olympus Medical Systems Corporation · 2023 · cites it directly2descendants
- K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation · 2023 · cites it directly1descendant
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp. · 2025 · 2 generations on0descendants
- K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation · 2025 · 2 generations on0descendants
- K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −5 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −4 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −1 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| 0 (this device) | K131780 | Evis Exera Iii Video System | Olympus Medical Systems Corp. | 2013 | — |
| +1 | K222584 | Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus… | Olympus Medical Systems Corporation | 2023 | 1 |
| +1 | K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus… | Olympus Medical Systems Corporation | 2023 | — |
| +2 | K250862 | Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii… | Olympus Medical Systems Corp. | 2025 | Class I |
| +2 | K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L… | Fujifilm Corporation | 2025 | — |
| +2 | K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI)… | Olympus Medical Systems Corporation | 2025 | — |
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 | 4 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 3 | 1 |
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.
4 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? (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 |
|---|---|---|---|
| * | K112680 | Evis Exera Iii Video SystemSummary page 1…NWB (endoscope, accessories, narrow band spectrum) 3. Predicate Devices 0 EVIS EXERA III VIDEO SYSTEM (K 112680) Page 2 of 4… | 2012 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222584 | Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I… | 2023 | 2 |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100… | 2023 | 1 |
| K232244 | Disposable Endoscope Valves System | 2023 | 0 |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope… | 2020 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2024 | Class II | Z-1210-2024 | Nonconforming Material/Component | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. |
| Oct 16, 2023 | Class II | Z-0416-2024 | Process control | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to… |
| Oct 16, 2023 | Class II | Z-0417-2024 | Process control | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to… |
| Oct 16, 2023 | Class II | Z-0418-2024 | Process control | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to… |
| Oct 16, 2023 | Class II | Z-0419-2024 | Process control | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to… |
| Oct 16, 2023 | Class II | Z-0415-2024 | Process control | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to… |
| Sep 25, 2023 | Class II | Z-0341-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Sep 14, 2023 | Class II | Z-0056-2025 | Nonconforming Material/Component | Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit. |
The 5 latest of 8 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 · 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 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 2 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 17 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K222584 (Olympus Medical Systems Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K112680.
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. 2013, 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?
Endoscoies (GASTROINTESTINAL VIDEOSCOPE GIF-HI1190. GIF-HOI 90. COLONOVIDEOSCOPE CF-HQl SOIl. CF-HI9SOLI. PCF-HI9OUJI. PCF-PHI9OLtIf This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-H01901Jl1), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The EVIS EXERA III…
Read the full statement (167 words)
Endoscoies (GASTROINTESTINAL VIDEOSCOPE GIF-HI1190. GIF-HOI 90. COLONOVIDEOSCOPE CF-HQl SOIl. CF-HI9SOLI. PCF-HI9OUJI. PCF-PHI9OLtIf
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-H01901Jl1), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA Ill COLONOVIDEOSCOPE CF-H19OLII, CF-HQI9OLII, POF-PH19OLI, PCF-H1SOLJI are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
CV-1 90 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, Endomherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
CLV-l90 XENON LIGHT SOURCE
This light source is intended to be used With Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131780: Evis Exera Iii Video System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131780
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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