510(k) · Cleared
Recalled · Class I · 2025Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
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 Feb 10, 2005 as substantially equivalent to K023984 (The Olympus Optical Co., 2003) and 1 other predicate after a 10-day review. Its family tree reaches back 5 generations to 1984. 2 of the 12 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Feb 10, 2005
- Review
- 10 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 5 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844002 (1984). 11 ancestors in all. No later device cites it as a predicate yet. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- This deviceK050220 Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC…Olympus Medical Systems Corporation · 2005
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…direct predicate · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| 0 (this device) | K050220 | Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC | Olympus Medical Systems Corporation | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 1 |
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…cessories 21 CFR 874.4680 I EOQ 3. Predicate Device Predicate Device Name Manufacturer 510(k) Number EVIS EXERA Bronchovideoscope Olympus Corporation K023984 Olympus BF type 160 EVIS EXERA Bronchovideoscope Olympus Corporation K023984 Olympus BF type 1T160 Olympus Sterilization Trays… | 2003 |
| * | K033222 | Olympus Sterilization TraysSummary page 2…tion K023984 Olympus BF type 160 EVIS EXERA Bronchovideoscope Olympus Corporation K023984 Olympus BF type 1T160 Olympus Sterilization Trays Olympus Winter & Ibe GMBH | K033222 4. Device Description The subject devices, Olympus EVIS EXERA Bronchovideoscope XBF-160Y3AC, XBF-1T160Y3AC, and XBF-Q160Y2AC are… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2025 | Class I | Z-0062-2026 | 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-0190-2024 | 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. |
| Jul 27, 2023 | Class II | Z-2492-2023 | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
| Aug 16, 2021 | Class II | Z-2573-2021 | 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-3302-2018 | 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 · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 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?
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, videc monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving.…
Read the full statement (209 words)
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, videc monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving.
The MAJ-1214 is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing.
The FB-52C-1 has been designed to be used with an Olympus endoscope to collect tissue within the thoracic and abdominal cavities and the airways and tracheobrochial tree.
This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies, caluculi or tissue specimens from the digestive tract, urinary tract, female reproductive tract and respiratory organs.
The Olympus IE-2P magnetic Extractor has been specially designed to be used within the airways and tracheobrochial tree.
These instruments have been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the thoracic and abdominal cavities and the airways and tracheobrochial tree.
These measuring devices have been designed for measuring leisions within the thoracic and abdominal cavities and the airways and tracheobochial 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/K050220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050220: Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050220
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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