510(k) · Cleared
Recalled · Class II · 2023Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Oct 16, 2003 as substantially equivalent to K023984 (The Olympus Optical Co., 2003) and 1 other predicate after a 10-day review. Its family tree reaches back 3 generations to 1993. 2 of the 65 devices in its family, counting itself, have a Class I recall. 60 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 16, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931154 (1993). 4 ancestors in all, the oldest K910423 (1991). 60 later devices descend from it, 3 citing it directly. 2 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 2 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 1 generation backK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- This deviceK033225 Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its…Olympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 2 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · cites it directly · 13 of its ownK051886 Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005
- Descendant · 2 generations on · 11 of its ownK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- Descendant · 2 generations on · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 60 · See all- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · cites it directly43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 2 generations on28descendants
- K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005 · cites it directly13descendants
- K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation · 2007 · 2 generations on11descendants
- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −2 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −1 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| 0 (this device) | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +2 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +1 | K051886 | Olympus Choledochoscope, Model XCHF-BP160F | Olympus Medical Systems Corporation | 2005 | — |
| +2 | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | 3 |
| +2 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 1 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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.
2 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? (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 |
|---|---|---|---|
| * | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesSummary page 2…_IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE Model 510(k)# Manufacturer Class | Product Code OES Bronchofiberscope Olympus BF | #K023984 | Olympus Optical Co., Ltd.‘ I EOQ type XP40 EVIS EXERA Bronchovideoscope #K023984 | Olympus Optical Co., Ltd. il EOQ Olympus BF… | 2003 |
| * | K931154 | Evis 200 SystemSummary page 2…| Olympus Optical Co., Ltd.‘ I EOQ type XP40 EVIS EXERA Bronchovideoscope #K023984 | Olympus Optical Co., Ltd. il EOQ Olympus BF type 160 OES Video Converter Olympus #K931154 | Olympus Optical Co., Ltd. I EOQ OVC-200 2, 3. 4. . DEVICE DESCRIPTION . Summary The subject device, EVIS EXERA Bronchofib… | 1993 |
What descends from it? (60)
See all 603 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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-2491-2023 | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
| Mar 8, 2022 | Class II | Z-1048-2022 | 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-2569-2021 | 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 8, 2018 | Class II | Z-3305-2018 | 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. |
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 · ◆ on the line of descent in FIG. 114 Class I recalls
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K042140 (Olympus Corporation, 2004) has gone furthest, with 43 descendants of its own.
- 8 other devices also cite its predicate K023984.
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?
The EVIS EXERA Bronchofibervideoscope Olympus BF type XP160F 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 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/K033225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033225: Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033225
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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