510(k) · Cleared
Recalled · 2009Bronchovideoscope Olympus XBF-D160HM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corporation · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Apr 19, 2004 as substantially equivalent to K023984 (The Olympus Optical Co., 2003) after a 7-day review. Its family tree reaches back 3 generations to 1993. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Apr 19, 2004
- Review
- 7 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931154 (1993). 4 ancestors in all, the oldest K910423 (1991). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has 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 deviceK040940 Bronchovideoscope Olympus XBF-D160HMOlympus Corporation · 2004
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 |
|---|---|---|---|---|---|
| −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) | K040940 | Bronchovideoscope Olympus XBF-D160HM | Olympus Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesSummary page 1…Predicate Device Name: EVIS EXERA Bronchovideoscope Olympus BF type 160 Manufacturer: Olympus Optical Co., Ltd. 510(k) Number: K023984 1/2 4. Device Description The subject device, Bronchovideoscope… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2009 | Not classified | Z-0917-2010 | Process control | Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of… |
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
What does this lineage say?
- The line of descent spans 11 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.
- 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?
This instrument 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 as stated in the FDA summary.
https://510kreport.com/device/K040940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040940: Bronchovideoscope Olympus XBF-D160HM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040940
Report an extraction error
Are you the manufacturer?
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