510(k) · Cleared
Recalled · Class II · 2023BF 240/P240/IT240 Bronchovideoscope & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Sep 9, 1996 as substantially equivalent to K931154 (Olympus Corp., 1993) after a 35-day review. Its family tree reaches back 1 generation to 1993. 14 of the 575 devices in its family, counting itself, have a Class I recall. 573 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 9, 1996
- Review
- 35 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931154 (1993). 573 later devices descend from it, 4 citing it directly. 14 of the 575 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK931154 Evis 200 SystemOlympus Corp. · 1993
- This deviceK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996
- Descendant · cites it directly · 431 of its ownK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 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 · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- Descendant · 2 generations on · 176 of its ownK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- Descendant · 3 generations on · 160 of its ownK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
Showing 5 of 573 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 573 · See all- K981543Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…The Olympus Optical Co. · 1998 · cites it directly431descendants
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · cites it directly350descendants
- K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · 2 generations on268descendants
- K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd. · 2001 · 2 generations on176descendants
- K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002 · 3 generations on160descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| 0 (this device) | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | — |
| +1 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| +1 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| +2 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| +2 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| +3 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 1 |
| 2004 | 6 | 0 |
| 2005 | 9 | 1 |
| 2006 | 6 | 1 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 15 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 20 | 0 |
| 2013 | 11 | 1 |
| 2014 | 20 | 0 |
| 2015 | 18 | 0 |
| 2016 | 14 | 0 |
| 2017 | 14 | 0 |
| 2018 | 24 | 0 |
| 2019 | 41 | 2 |
| 2020 | 38 | 1 |
| 2021 | 36 | 1 |
| 2022 | 38 | 0 |
| 2023 | 49 | 1 |
| 2024 | 56 | 3 |
| 2025 | 72 | 2 |
| 2026 | 41 | 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.
14 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? (1)
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 |
|---|---|---|---|
| * | K931154 | Evis 200 SystemSummary page 1…ries Common/Usual Name: Bronchovideoscope and Accessories Classification Name: Bronchoscope and Accessories Predicate Devices: Olympus EVIS 200 System - Bronchoscopy (K931154) Submitted By: Mr. Barry E. Sands (Contact Person) Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville… | 1993 |
What descends from it? (573)
See all 5734 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary… | 1998 | 431 |
| K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series Class I | 2003 | 350 |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | 2001 | 59 |
| K021204 | Olympus BF Type UM40 | 2002 | 44 |
Has anything in its family been recalled? (14 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0337-2024 | 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… |
| 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-2503-2023 | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
| Aug 8, 2018 | Class II | Z-3298-2018 | 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-3289-2018 | 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-3286-2018 | 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 6 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 · 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
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 8 generations on · ◆ in the 2024 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
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
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 BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment 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/K963033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963033
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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