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 Corporation · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Feb 16, 2012 as substantially equivalent to K100584 (Olympus Medical Systems Corporation, 2010) and 4 other predicates after a 155-day review. Its family tree reaches back 8 generations to 1993. 4 of the 87 devices in its family, counting itself, have a Class I recall. 57 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 16, 2012
- Review
- 155 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 8 generations to K931154 (1993). 29 ancestors in all, the oldest K843084 (1985). 57 later devices descend from it, 5 citing it directly. 4 of the 87 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 deviceK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012
- Descendant · cites it directly · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- Descendant · cites it directly · 19 of its ownK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- Descendant · 2 generations on · 12 of its ownK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU…KARL STORZ Endoscopy-America, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK131780 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · Recalled
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 57 · See all- K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · cites it directly19descendants
- K122831Video System CenterOlympus Medical Systems Corp. · 2012 · cites it directly19descendants
- K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017 · 2 generations on12descendants
- K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc. · 2015 · 2 generations on7descendants
- K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · cites it directly7descendants
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) | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | — |
| +1 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
| +1 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| +2 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| +2 | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015 | — |
| +1 | K131780 | Evis Exera Iii Video System | Olympus Medical Systems Corp. | 2013 | 8 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 1 |
| 2026 | 4 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K100584 | Evis Exeraii 180 SystemSummary page 2…te Device Information Subject Device Predicate Device Predicate {Part of this submission) Device 510(k) No. GASTROINTESTINAL VIDEOSCOPE | EVIS EXERA |l GASTROINTESTINAL K100584 OLYMPUS GIF TYPE H190 VIDEOSCOPE (GIF-H190) OLYMPUS GIF TYPE H180 (GIF-H180) GASTROINTESTINAL VIDEOSCOPE | EVIS EXERA Il GASTROIN… | 2010 |
| * | K011151 | Evis Exera Gastrointestinal Videoscope Gif-Q160ZSummary page 2…DEOSCOPE | EVIS EXERA Il GASTROINTESTINAL K100584 OLYMPUS GIF TYPE HQ190 VIDEOSCOPE (GIF-HQ190) OLYMPUS GIF TYPE H180 (GIF-H180) EVIS EXERA Gastrointestinal Videoscope | K011151 GIF-Q1602 (Herein after referred to as GIF-Q160Z) COLONOVIDEOSCOPE EVIS EXERA Il COLONOVIDEOSCOPE K100584 OLYMPUS CF TYPE HQ190L… | 2001 |
| * | K002749 | Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13DSummary page 2…CF TYPE H180AL (CF-HQ190L) (CF-H180AL) EVIS EXERA Gastrointestinal Videoscope | KO11151 GIF-Q160Z {Herein after referred to as GIF-Q160Z) Colonovideoscope XCF-Q140L/13D K002749 (Herein after referred to as XCF-Q140L/13D) COLONOVIDEOSCOPE EVIS EXERA It COLONOVIDEOSCOPE K100584 OLYMPUS CF TYPE HQ190I OLYMPU… | 2000 |
| * | K051645 | Evis Exera 160A SystemSummary page 3…(PCF-HiBOAI) _____ OLYMPUS CV-190 EVIS EXERA Video system Center K051645 VIDEO SYSTEM CENTER OLYMPUS CV-160A (CV-1 90) (CV-160A)… | 2005 |
| * | K062049 | Evis Exera II 180 SystemSummary page 3…OLYMPUS CV-160A (CV-1 90) (CV-160A) EVIS EXERA 11VIDEO SYSTEM CENTER K062049 OLYMPUS CV-180 K100584… | 2006 |
What descends from it? (57)
See all 575 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1211-2024 | 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. |
| Jan 11, 2024 | Class II | Z-1207-2024 | 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. |
| Jan 11, 2024 | Class II | Z-1206-2024 | 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 2, 2023 | Class II | Z-0288-2024 | Reprocessing Controls | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| Sep 25, 2023 | Class II | Z-0329-2024 | 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 25, 2023 | Class II | Z-0334-2024 | 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… |
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 · 3 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 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 16 of the 29 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K123365 (Olympus Medical Systems Corp., 2013) has gone furthest, with 19 descendants of its own.
- 21 other devices also cite its predicate K100584.
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. 2012, 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 an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I), 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…
Read the full statement (146 words)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I), 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 III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190I/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112680 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112680: Evis Exera Iii Video System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112680
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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