510(k) · Cleared
Recalled · Class II · 2023Evis Exera 160A System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · NWB Endoscope, Accessories, Narrow Band Spectrum
Cleared on Oct 13, 2005 as substantially equivalent to K954451 (Olympus America, Inc., 1996) and 3 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1986. 5 of the 215 devices in its family, counting itself, have a Class I recall. 208 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 13, 2005
- Review
- 115 days
- Class
- Class II
- Product code
- NWB
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 2 generations to K853585 (1986). 6 ancestors in all. 208 later devices descend from it, 9 citing it directly. 5 of the 215 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 1 generation backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- This deviceK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005
- Descendant · cites it directly · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · cites it directly · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · cites it directly · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · cites it directly · 57 of its ownK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- Descendant · 2 generations on · 34 of its ownK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · Recalled
Showing 5 of 208 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 208 · See all- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · cites it directly158descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · cites it directly158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · cites it directly132descendants
- K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · cites it directly57descendants
- K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| 0 (this device) | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | — |
| +1 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +1 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| +1 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +1 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| +2 | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | Olympus Medical Systems Corp. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 1 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 1 |
| 2014 | 8 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 11 | 0 |
| 2019 | 17 | 1 |
| 2020 | 22 | 0 |
| 2021 | 12 | 1 |
| 2022 | 15 | 0 |
| 2023 | 20 | 0 |
| 2024 | 22 | 0 |
| 2025 | 27 | 1 |
| 2026 | 17 | 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 NWB device
- #1 K211882 HD-550 Video Endoscope Systemscore 8.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K954451 | Evis 140 SystemSummary page 2…e 16-2. Primar Coinonents & Predicate Devices of the EVIS EXERA 160A Sstem EVIS EXERA Xenon Light Source EVIS Universal Light Source CLV-U40 K954451 Olympus CLV-160A EVIS EXERA Video System Center EVIS Video System Center CV-140 K954451 Olympus… | 1996 |
| * | K001766 | Olympus Xgif-N200H Gastrointestinal VideoscopeSummary page 7…ison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 Predicate Device: XGIF-N200H Gastrointestinal Videoscope (K001766) ~ ~:~~iflaton m/> e~ Ice'? _:¢_ gcaete Device Field of View… | 2000 |
| * | K011151 | Evis Exera Gastrointestinal Videoscope Gif-Q160ZSummary page 7…ison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 Predicate Device: EVIS EXERA Gastrointestinal Videoscope GIF-QI60Z (K011151) Subject Devie" j Pred6hWevice Field of View 140 *… | 2001 |
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 8…. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XCF-Q16OW6L Predicate Device: EVIS EXERA Colonovideoscope CF-Q160AL (K001241) 4~;1 Subject Device4 h',~'Predicate D1)6icel… | 2000 |
What descends from it? (208)
See all 2089 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062049 | Evis Exera II 180 System | 2006 | 158 |
| K061313 | Evis Exera 180 System Class I | 2006 | 158 |
| K100584 | Evis Exeraii 180 System | 2010 | 132 |
| K112680 | Evis Exera Iii Video System | 2012 | 57 |
| K072957 | Evis Exera II 180 System | 2008 | 17 |
| K121959 | Evis Exera Iii Video System Class I | 2013 | 14 |
| K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source… | 2009 | 11 |
| K100624 | Invendo C20 Colonoscopy System | 2012 | 6 |
| K101053 | Olympus CF Type Y0023-L, Y0023I | 2010 | 0 |
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… |
| 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… |
| Dec 17, 2018 | Class II | Z-1008-2019 | Under Investigation by firm | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair. |
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 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 3 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 · 3 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K062049 (Olympus Medical Systems Corporation, 2006) has gone furthest, with 158 descendants of its own.
- 9 other devices also cite its predicate K954451.
How does its category compare?
All NWB devicesNWB Endoscope, Accessories, Narrow Band Spectrum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NWB
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NWB
Too few NWB 510(k)s in any year since 2007 to give a median.
Recalls per year · NWB
5in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NWB
2,847in 2025
MAUDE reports naming product code NWB, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 1 | — | 3 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 823 |
| 2021 | 0 | — | 0 | 1,453 |
| 2022 | 2 | — | 0 | 1,828 |
| 2023 | 0 | — | 5 (2) | 2,180 |
| 2024 | 0 | — | 0 | 2,648 |
| 2025 | 0 | — | 0 | 2,847 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. This instrument has been designed to be used…
Read the full statement (204 words)
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, 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, sigmoid colon, colon and ileocecal valve).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051645: Evis Exera 160A System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051645
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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