510(k) · Cleared
Recalled · Class II · 2023Evis 140 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Mar 29, 1996 as substantially equivalent to K853585 (Olympus Corp., 1986) and 1 other predicate after a 186-day review. Its family tree reaches back 1 generation to 1986. 6 of the 321 devices in its family, counting itself, have a Class I recall. 318 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 29, 1996
- Review
- 186 days
- Class
- Class II
- Product code
- FET
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K853585 (1986). 2 ancestors in all. 318 later devices descend from it, 10 citing it directly. 6 of the 321 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- This deviceK954451 Evis 140 SystemOlympus America, Inc. · 1996
- 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 · cites it directly · 75 of its ownK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
Showing 5 of 318 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 318 · 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
- K971660Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Olympus America, Inc. · 1997 · cites it directly75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| 0 (this device) | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | — |
| +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 |
| +1 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 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), 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.
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? (2)
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 |
|---|---|---|---|
| * | K853585 | Olympus Evs-Endoscopic Video Image & Data SysSummary page 1…System, associated endoscope, and ancillary equipment and endoscopic accessories Olympus EVIS 140 System Endoscope and Accessories Olympus EVS Video Endoscopy System (K853585) Olympus EVIS 200 System - Bronchoscopy (K931154) Refer to Subsection I-A for additional list of predicate devices. Mr. Barry Sa… | 1986 |
| * | K931154 | Evis 200 SystemSummary page 1…ment and endoscopic accessories Olympus EVIS 140 System Endoscope and Accessories Olympus EVS Video Endoscopy System (K853585) Olympus EVIS 200 System - Bronchoscopy (K931154) Refer to Subsection I-A for additional list of predicate devices. Mr. Barry Sands Olympus America Inc. Endoscope Division Two… | 1993 |
What descends from it? (318)
See all 31810 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 |
| K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary… | 1997 | 75 |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | 2001 | 59 |
| K984358 | Olympus Distal Attachment, Models… | 1999 | 30 |
| K032177 | Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I… | 2003 | 15 |
| K023259 | Inhealth Soft Sleeve Colonoscope Splint, Model CS1200 | 2002 | 6 |
| K031256 | Xsif-1TQ140A Small Intestinal Videoscope | 2003 | 5 |
| K980465 | Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus… | 1998 | 2 |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | 2026 | 0 |
| K123047 | Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set | 2013 | 0 |
Has anything in its family been recalled? (6 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… |
| 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… |
| Sep 25, 2023 | Class II | Z-0346-2024 | 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
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 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?
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 | — |
What is it indicated for?
The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliaty duct, duodenum, small intestine, rectum and colon. The intended use of EVIS 140 System and associated endoscopes are identical to the currently marketed EVS…
Read the full statement (117 words)
The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliaty duct, duodenum, small intestine, rectum and colon.
The intended use of EVIS 140 System and associated endoscopes are identical to the currently marketed EVS System which was cleared for marketing in the 510(k) # K853585. Both systems are used for observation, photo and video documentation of the images within the upper and lower GI tract. Thus, when compared to the predicate device, Olympus EVIS 140 System does not raise any questions regarding the safety of the subject device.
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/K954451 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954451: Evis 140 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954451
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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