510(k) · Cleared
Recalled · Class I · 2025Evis Exera Iii Video System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jan 10, 2013 as substantially equivalent to K061313 (Olympus Medical Systems Corporation, 2006) and 3 other predicates after a 189-day review. Its family tree reaches back 8 generations to 1993. 7 of the 43 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 10 times, including 8 Class I recalls.
- Decided
- Jan 10, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 10 (8 Class I)
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931154 (1993). 28 ancestors in all, the oldest K843084 (1985). 14 later devices descend from it, 4 citing it directly. 7 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 4 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 3 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 2 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 1 generation backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- This deviceK121959 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013
- Descendant · cites it directly · 7 of its ownK172726 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use…Olympus Medical Systems Corp. · 2018 · Recalled
- Descendant · cites it directly · 3 of its ownK143727 PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK183419 EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK173679 PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK232860 PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video…Pentax of America, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp. · 2018 · cites it directly7descendants
- K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc. · 2015 · cites it directly3descendants
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 2 generations on2descendants
- K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc. · 2018 · 2 generations on2descendants
- K232860PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…Pentax of America, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −4 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −3 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −2 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −1 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| 0 (this device) | K121959 | Evis Exera Iii Video System | Olympus Medical Systems Corp. | 2013 | — |
| +1 | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy… | Olympus Medical Systems Corp. | 2018 | 2 |
| +1 | K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | Pentax of America, Inc. | 2015 | — |
| +2 | K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | 2019 | Class I |
| +2 | K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax of America, Inc. | 2018 | — |
| +3 | K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope… | Pentax of America, Inc. | 2024 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 0 |
| 2021 | 2 | 1 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 1 |
| 2026 | 1 | 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 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 |
|---|---|---|---|
| * | K061313 | Evis Exera 180 SystemSummary page 2…OLYMPUS CO., LTD. LIGHT SOURCE CLV-160A 31 EVIS EXERA 11 XENON K061313 LIGHT SOURCE K062049 OLYMPUS CLV-180… | 2006 |
| * | K051645 | Evis Exera 160A SystemSummary page 2…OLYMPUS BF TYPE 1 Ti80 _______ __________ OLYMPUS CLV-190 EVIS EXERA Xenon Light K051645 SHIRAKAWA EVIS EXERA MI XENON Source OLYMPUS OLYMPUS CO., LTD. LIGHT SOURCE… | 2005 |
| * | K062049 | Evis Exera II 180 SystemSummary page 2…A 31 EVIS EXERA 11 XENON K061313 LIGHT SOURCE K062049 OLYMPUS CLV-180 K100584 OLYMPUS CV-190 EVIS EXERA Video… | 2006 |
| * | K100584 | Evis Exeraii 180 SystemSummary page 2…EVIS EXERA 11 XENON K061313 LIGHT SOURCE K062049 OLYMPUS CLV-180 K100584 OLYMPUS CV-190 EVIS EXERA Video K051645 EVIS EXERA Iff VIDEO System Cente… | 2010 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | 2018 | 7 |
| K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | 2015 | 3 |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100… | 2023 | 1 |
| K252341 | Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope… | 2026 | 0 |
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2025 | Class I | Z-0049-2026 | 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-0053-2026 | 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-0060-2026 | 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-0063-2026 | 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-0050-2026 | 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-0192-2024 | 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-0327-2024 | 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-2496-2023 | 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-2017-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Jun 8, 2023 | Class I | Z-2015-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
The 5 latest of 10 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
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 2 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 · 2 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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 16 of the 28 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K172726 (Olympus Medical Systems Corp., 2018) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K061313.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
-Endoscopes (OLYMPUS BF-O190, OLYMPUS BF-H190, OLYMPUS BF-1TH19O EVIS EXERA III BRONCHOVIDEOSCOPE) This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endoherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. -OLYMPUS CV-190 EVIS EXERA II…
Read the full statement (129 words)
-Endoscopes (OLYMPUS BF-O190, OLYMPUS BF-H190, OLYMPUS BF-1TH19O EVIS EXERA III BRONCHOVIDEOSCOPE)
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endoherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
-OLYMPUS CV-190 EVIS EXERA II VIDEO SYSTEM CENTER
This video system center is intended 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.
- OLYMPUS CLV-190 EVIS EXERA I XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121959 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121959: Evis Exera Iii Video System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121959
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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