510(k) · Cleared
Recalled · Class II · 2023Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on May 9, 2000 after a 21-day review. The FDA summary names no predicate by number. 5 of the 259 devices in its family, counting itself, have a Class I recall. 258 later devices descend from it. It has been recalled once.
- Decided
- May 9, 2000
- Review
- 21 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 1
- Predicates
- 0
258 later devices descend from it, 15 citing it directly. 5 of the 259 devices in this family, counting this one, have a Class I recall.
- This deviceK001241 Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co. · 2000
- Descendant · cites it directly · 208 of its ownK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · Recalled
- Descendant · 2 generations on · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · 2 generations on · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 2 generations on · 57 of its ownK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
Showing 5 of 258 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 258 · See all- K051645Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · cites it directly208descendants
- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on158descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 2 generations on132descendants
- K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · 2 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I | The Olympus Optical Co. | 2000 | — |
| +1 | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | 3 |
| +2 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +2 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| +2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +2 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 1 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 1 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 12 | 0 |
| 2019 | 18 | 1 |
| 2020 | 23 | 0 |
| 2021 | 14 | 1 |
| 2022 | 19 | 0 |
| 2023 | 25 | 0 |
| 2024 | 27 | 0 |
| 2025 | 31 | 1 |
| 2026 | 18 | 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.
5 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?
The FDA summary names no predicate by number.
What descends from it? (258)
See all 25815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051645 | Evis Exera 160A System | 2005 | 208 |
| K102581 | Defendo Disposable Suction Valve Model 100305 | 2010 | 22 |
| K102409 | Defendo Disposable Air/Water Valve Model 100304 | 2010 | 21 |
| K032177 | Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I… | 2003 | 15 |
| K131855 | Pentax Video Colonoscopes (EC Family) | 2014 | 13 |
| K052930 | Navigator Endoscopy System | 2006 | 13 |
| K070622 | Neoguide Endoscopy System | 2007 | 12 |
| K100624 | Invendo C20 Colonoscopy System | 2012 | 6 |
| K031256 | Xsif-1TQ140A Small Intestinal Videoscope | 2003 | 5 |
| K051551 | Small Intestinal Videoscope System | 2005 | 4 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
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 on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K051645 (Olympus Medical Systems Corporation, 2005) has gone furthest, with 208 descendants of its own.
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.
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?
The EVIS EXERA Colonovideoscopes CF-Q160 AL/l and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, sigmoid colon, colon and ileocecal valve).
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/K001241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001241
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026