510(k) · Cleared
ClearedEvis Exera Colonovideoscope Model XCF-Q160W1L/1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aizu Olympus Co., Ltd. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jan 28, 2005 as substantially equivalent to K001241 (The Olympus Optical Co., 2000) after a 42-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jan 28, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001241 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001241 Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co. · 2000 · Recalled
- This deviceK043487 Evis Exera Colonovideoscope Model XCF-Q160W1L/1Aizu Olympus Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I | The Olympus Optical Co. | 2000 | 1 |
| 0 (this device) | K043487 | Evis Exera Colonovideoscope Model XCF-Q160W1L/1 | Aizu Olympus Co., Ltd. | 2005 | — |
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.
Planning a device in FDF? 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 |
|---|---|---|---|
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 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.
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 has been designed to be used with the Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical Unit, Endo-therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid 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/K043487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043487: Evis Exera Colonovideoscope Model XCF-Q160W1L/1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043487
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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