510(k) · Cleared
Recalled · Class II · 2018Olympus Evs-Endoscopic Video Image & Data Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jan 21, 1986 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 321 devices in its family, counting itself, have a Class I recall. 320 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 21, 1986
- Review
- 148 days
- Class
- Class II
- Product code
- FET
- Recalls
- 2
- Predicates
- 0
320 later devices descend from it, 4 citing it directly. 6 of the 321 devices in this family, counting this one, have a Class I recall.
- This deviceK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986
- Descendant · cites it directly · 318 of its ownK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 208 of its ownK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · Recalled
- Descendant · 3 generations on · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · 3 generations on · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
Showing 5 of 320 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 320 · See all- K954451Evis 140 SystemOlympus America, Inc. · 1996 · cites it directly318descendants
- K051645Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · 2 generations on208descendants
- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on158descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 3 generations on132descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | — |
| +1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| +2 | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | 3 |
| +3 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| +3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 1 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 12 | 0 |
| 2013 | 8 | 1 |
| 2014 | 13 | 0 |
| 2015 | 11 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 17 | 0 |
| 2019 | 26 | 1 |
| 2020 | 27 | 1 |
| 2021 | 14 | 1 |
| 2022 | 19 | 0 |
| 2023 | 25 | 0 |
| 2024 | 23 | 0 |
| 2025 | 36 | 1 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (320)
See all 3204 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2018 | Class II | Z-2270-2018 | Under Investigation by firm | Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection. |
| May 11, 2018 | Class II | Z-2269-2018 | Under Investigation by firm | Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning… |
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 on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 5 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 · 5 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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K954451 (Olympus America, Inc., 1996) has gone furthest, with 318 descendants of its own.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
https://510kreport.com/device/K853585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K853585: Olympus Evs-Endoscopic Video Image & Data Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853585
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026