510(k) · Cleared
Recalled · Class II · 2024Evis Exeraii 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 Jul 2, 2010 as substantially equivalent to K051645 (Olympus Medical Systems Corporation, 2005) and 2 other predicates after a 122-day review. Its family tree reaches back 7 generations to 1993. 7 of the 160 devices in its family, counting itself, have a Class I recall. 132 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 2, 2010
- Review
- 122 days
- Class
- Class II
- Product code
- NWB
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931154 (1993). 27 ancestors in all, the oldest K843084 (1985). 132 later devices descend from it, 22 citing it directly. 7 of the 160 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 3 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 2 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 1 generation backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- This deviceK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010
- 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 · 2 generations on · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- Descendant · 2 generations on · 19 of its ownK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- Descendant · cites it directly · 16 of its ownK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
Showing 5 of 132 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 132 · See all- 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
- K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · 2 generations on19descendants
- K122831Video System CenterOlympus Medical Systems Corp. · 2012 · 2 generations on19descendants
- K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −3 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −2 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −1 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| 0 (this device) | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | — |
| +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 |
| +2 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
| +2 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| +1 | K140149 | Epx-4440HD Digital Video Processor | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 6 | 0 |
| 2013 | 5 | 1 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 8 | 0 |
| 2019 | 8 | 1 |
| 2020 | 16 | 0 |
| 2021 | 9 | 1 |
| 2022 | 7 | 0 |
| 2023 | 11 | 0 |
| 2024 | 15 | 0 |
| 2025 | 19 | 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.
7 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? (3)
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…0AY2L Subject Devnce Predicate D v 5':2 i (Part of this Submlsswn) e lca e_ svice ' “Né ) EVIS EXERA Il XENON LIGHT SOURCE OLYMPUS CLV-180 EVIS EXERA Xenon Light Source K051645 (Hereinafter referred to as CLV-180) Olympus CLV-160A (K061313, K062049) EVIS EXERA Il VIDEO SYSTEM CENTER OLYMPUS CV-180 EVIS EX… | 2005 |
| * | K061313 | Evis Exera 180 SystemSummary page 2…swn) e lca e_ svice ' “Né ) EVIS EXERA Il XENON LIGHT SOURCE OLYMPUS CLV-180 EVIS EXERA Xenon Light Source K051645 (Hereinafter referred to as CLV-180) Olympus CLV-160A (K061313, K062049) EVIS EXERA Il VIDEO SYSTEM CENTER OLYMPUS CV-180 EVIS EXERA Video System Center K051645 (Hereinafter referred to as CV-… | 2006 |
| * | K062049 | Evis Exera II 180 SystemSummary page 2…a e_ svice ' “Né ) EVIS EXERA Il XENON LIGHT SOURCE OLYMPUS CLV-180 EVIS EXERA Xenon Light Source K051645 (Hereinafter referred to as CLV-180) Olympus CLV-160A (K061313, K062049) EVIS EXERA Il VIDEO SYSTEM CENTER OLYMPUS CV-180 EVIS EXERA Video System Center K051645 (Hereinafter referred to as CV-180) .Oly… | 2006 |
What descends from it? (132)
See all 13222 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112680 | Evis Exera Iii Video System | 2012 | 57 |
| K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | 2012 | 34 |
| K140149 | Epx-4440HD Digital Video Processor | 2014 | 16 |
| K121959 | Evis Exera Iii Video System Class I | 2013 | 14 |
| K131855 | Pentax Video Colonoscopes (EC Family) | 2014 | 13 |
| K131902 | Pentax Video Upper G.I. Scopes (EG Family) | 2014 | 10 |
| K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | 2023 | 6 |
| K122470 | Pentax Epk-I5010 Video Processor | 2013 | 6 |
| K212382 | Ambu® aScope™ Gastro, Ambu® aBox™2 | 2022 | 2 |
| K201098 | Ambu Duodeno System | 2020 | 2 |
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2024 | Class II | Z-1208-2024 | Nonconforming Material/Component | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. |
| Jan 11, 2024 | Class II | Z-1209-2024 | Nonconforming Material/Component | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. |
| Jan 11, 2024 | Class II | Z-1214-2024 | Nonconforming Material/Component | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. |
| Jan 11, 2024 | Class II | Z-1205-2024 | Nonconforming Material/Component | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. |
| 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 21, 2022 | Class II | Z-1132-2023 | Process design | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination |
| Apr 22, 2022 | Class II | Z-1274-2022 | Nonconforming Material/Component | A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm)… |
| Dec 17, 2018 | Class II | Z-1009-2019 | 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. |
The 5 latest of 9 recalls; the web page lists all.
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 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 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
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 15 of the 27 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K112680 (Olympus Medical Systems Corporation, 2012) has gone furthest, with 57 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. 2010, this device’s year, is highlighted.
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 sources, monitors, endo-therapy accessories and other ancillary equipment for…
Read the full statement (284 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 sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndloTherapy accessories (such as a biopsy forceps), and other ancillary equipment for transoral or transnasal endloscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180. OLYMPUS GIF TYPE H180
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endloscopy and endloscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL. OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI. OLYMPUS PCF TYPE Q180AL (Pediatric). OLYMPUS PCF TYPE Q180AI (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric). OLYMPUS PCF TYPE H180AI (Pediatric),
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endloscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, 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/K100584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100584: Evis Exeraii 180 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100584
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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