510(k) · Cleared
ClearedEvis Exera II 180 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 Sep 22, 2006 as substantially equivalent to K051645 (Olympus Medical Systems Corporation, 2005) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1993. 5 of the 176 devices in its family, counting itself, have a Class I recall. 158 later devices descend from it.
- Decided
- Sep 22, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- NWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931154 (1993). 17 ancestors in all, the oldest K843084 (1985). 158 later devices descend from it, 5 citing it directly. 5 of the 176 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 3 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 2 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 1 generation backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- This deviceK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- 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 · cites it directly · 34 of its ownK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · Recalled
- Descendant · cites it directly · 25 of its ownK133538 Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera…Olympus Corporation of the Americas · 2014
- Descendant · 2 generations on · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 158 · See all- 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 · cites it directly34descendants
- K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas · 2014 · cites it directly25descendants
- K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −3 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −2 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| 0 (this device) | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +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 |
| +1 | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | Olympus Medical Systems Corp. | 2012 | 1 |
| +1 | K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro… | Olympus Corporation of the Americas | 2014 | — |
| +2 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 1 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 8 | 0 |
| 2019 | 10 | 1 |
| 2020 | 18 | 0 |
| 2021 | 10 | 1 |
| 2022 | 12 | 0 |
| 2023 | 15 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 1 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K051645 | Evis Exera 160A SystemSummary page 2…- OLYMPUS CLV-180 __ _OLYMPUS CLV-1SA K564A K051645 _ _ EVIS EXERAlI VI SYSTEM CENTER Ey15 EXERA VID… | 2005 |
| * | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VASummary page 6…mparison of Specifications Subject Device: VISERA Cysto-Nephro Videoscope Olympus CYF type V2IVA2 Predicate Device: VISERA C stovideosco e O1 m us CYF type VNVA (K021074) Field of View 120° 1200 Depth of Field 3… | 2002 |
What descends from it? (158)
See all 1585 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100584 | Evis Exeraii 180 System | 2010 | 132 |
| K112680 | Evis Exera Iii Video System | 2012 | 57 |
| K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | 2012 | 34 |
| K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope… | 2014 | 25 |
| K121959 | Evis Exera Iii Video System Class I | 2013 | 14 |
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- 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 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 11 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K100584 (Olympus Medical Systems Corporation, 2010) has gone furthest, with 132 descendants of its own.
- 8 other devices also cite its predicate K051645.
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?
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 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. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 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…
Read the full statement (124 words)
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
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.
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
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.
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062049: Evis Exera II 180 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062049
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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