510(k) · Cleared
Recalled · Class II · 2023Bronchoscope BF-N20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Apr 29, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 of the 353 devices in its family, counting itself, have a Class I recall. 352 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 1991
- Review
- 89 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 2
- Predicates
- 0
352 later devices descend from it, 2 citing it directly. 13 of the 353 devices in this family, counting this one, have a Class I recall.
- This deviceK910423 Bronchoscope BF-N20Olympus Corp. · 1991
- Descendant · cites it directly · 350 of its ownK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 159 of its ownK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- Descendant · 2 generations on · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 2 generations on · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
Showing 5 of 352 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 352 · See all- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · cites it directly350descendants
- K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003 · 2 generations on159descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 3 generations on132descendants
- K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · 2 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910423 | Bronchoscope BF-N20 | Olympus Corp. | 1991 | — |
| +1 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| +2 | 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 |
| +3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +2 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 3 | 0 |
| 2005 | 6 | 1 |
| 2006 | 3 | 1 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 14 | 0 |
| 2013 | 7 | 1 |
| 2014 | 13 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 9 | 0 |
| 2018 | 16 | 0 |
| 2019 | 25 | 2 |
| 2020 | 28 | 1 |
| 2021 | 21 | 1 |
| 2022 | 20 | 0 |
| 2023 | 29 | 1 |
| 2024 | 31 | 2 |
| 2025 | 44 | 2 |
| 2026 | 27 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
13 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (352)
See all 3522 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2023 | Class II | Z-2502-2023 | 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-2564-2021 | 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." |
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 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 114 Class I recalls
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 5 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 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 12 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 13 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
Nearest 12 of 13 shown.
Nearest 5 of 13; all are on the web page.
What does this lineage say?
- Of its descendants, K023984 (The Olympus Optical Co., 2003) has gone furthest, with 350 descendants of its own.
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 | — |
https://510kreport.com/device/K910423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910423: Bronchoscope BF-N20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910423
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026