510(k) · Cleared
Recalled · Class I · 2026Evis Exera 180 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Aug 31, 2006 as substantially equivalent to K051645 (Olympus Medical Systems Corporation, 2005) and 3 other predicates after a 113-day review. Its family tree reaches back 6 generations to 1993. 6 of the 179 devices in its family, counting itself, have a Class I recall. 158 later devices descend from it. It has been recalled 19 times, including 6 Class I recalls.
- Decided
- Aug 31, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 19 (6 Class I)
- Predicates
- 4
Its longest line of descent runs back 6 generations to K931154 (1993). 20 ancestors in all, the oldest K850978 (1985). 158 later devices descend from it, 10 citing it directly. 6 of the 179 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 4 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 3 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 2 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 1 generation backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- This deviceK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · cites it directly · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 2 generations on · 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 · 3 generations on · 19 of its ownK122831 Video System CenterOlympus Medical Systems Corp. · 2012
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 · 2 generations on57descendants
- 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 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −5 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −4 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −3 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −2 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −1 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| 0 (this device) | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +1 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +2 | 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 | — |
| +3 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 1 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 12 | 1 |
| 2020 | 17 | 0 |
| 2021 | 10 | 1 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 21 | 1 |
| 2026 | 16 | 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K051645 | Evis Exera 160A SystemSummary page 3…ded for endoscopic diagnosis, treatment and video observation, The CLV-180 is identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-1 80 has an optional filter which allows the user to enhance e… | 2005 |
| * | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesSummary page 2…CENTER OLYMPUS CV-180 OLYMPUS CV-160A EVIS EXERA | BRONCHOVIDEOSCOPE OLYPUS BF TYPE P180 EVIS EXERA BRONCHOVIDEOSCOPE EVIS EXERA (| BRONCHOVIDEOSCOPE | OLYPUS BF TYPE160 K023984 OLYPUS BF TYPE Q180 £VIS EXERA I BRONCHOVIDEOSCOPE | EVIS EXERA BRONCHOVIDEOSCOPE OLYPUS 8F TYPE 17180 OLYPUS BF TYPE 17160 VISER… | 2003 |
| * | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VSummary page 2…£VIS EXERA I BRONCHOVIDEOSCOPE | EVIS EXERA BRONCHOVIDEOSCOPE OLYPUS 8F TYPE 17180 OLYPUS BF TYPE 17160 VISERA RHINO-LARYNGO VIDEOSCOPE | VISERA RHINO-LARYNGO VIDEOSCOPE K031648 OLYMPUS ENF TYPE V2 OLYMPUS ENF TYPE V VISERA RHINO-LARYNGO VIDEOSCOPE | VISERA RHINO-LARYNGC VIDEOSCOPE KO52452 OLYMPUS XENF TYP… | 2003 |
| * | K052452 | Visera Rhino-Laryngovideoscope Olympus Enf Type VTSummary page 9…parison of Specifications Subject Device: VISERA Rhino-Laryngovideoscope Olympus XENF type VTY1 Predicate Device: VISERA Rhino-Laryngovideoscope Olympus ENF type VT (K052452) Field of View 90" 90' Depth of Field… | 2005 |
What descends from it? (158)
See all 15810 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 |
| K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | 2012 | 34 |
| K121959 | Evis Exera Iii Video System Class I | 2013 | 14 |
| K220606 | Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 | 2022 | 10 |
| K162151 | PENTAX Medical ENT Video Imaging System | 2017 | 6 |
| K131028 | Pentax Video Bronchoscopes (EB Family) | 2014 | 3 |
| K182102 | Rhino-Laryngo Videoscope Olympus Enf-VH2, Rhino-Laryngo Videoscope Olympus Enf-V4 | 2019 | 1 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | 2023 | 0 |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3 | 2019 | 0 |
| K082174 | Y-Adapter | 2008 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2026 | Class II | Z-1489-2026 | Under Investigation by firm | Potential for rubber fragment detachment during use. |
| Jan 29, 2026 | Class II | Z-1488-2026 | Under Investigation by firm | Potential for rubber fragment detachment during use. |
| Sep 11, 2025 | Class I | Z-0051-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0061-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0046-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0056-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Oct 12, 2023 | Class I | Z-0191-2024 | Under Investigation by firm | There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. |
| Sep 25, 2023 | Class II | Z-0332-2024 | 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… |
| Jul 27, 2023 | Class II | Z-2493-2023 | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
| Jun 8, 2023 | Class I | Z-2016-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Mar 8, 2022 | Class II | Z-1049-2022 | Other | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization |
| Aug 16, 2021 | Class II | Z-2571-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 16, 2021 | Class II | Z-2572-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 31, 2020 | Class II | Z-3017-2020 | Device Design | The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes. |
| Aug 8, 2018 | Class II | Z-3285-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3297-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3288-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3301-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3310-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
The 5 latest of 19 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 114 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 13 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 20 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 EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other…
Read the full statement (178 words)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).
This instrument has 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 nasal lumens and airway anatomy (including nasopharyngeal and trachea).
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.
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 biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
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/K061313 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061313: Evis Exera 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/K061313
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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