510(k) · Cleared
ClearedEvis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · PSV Ultrasound Bronchoscope
Cleared on Aug 27, 2026 as substantially equivalent to K183525 (Olympus Medical Systems Corp., 2019) after a 202-day review. Its family tree reaches back 10 generations to 1989. 1 of the 61 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 27, 2026
- Review
- 202 days
- Class
- Class II
- Product code
- PSV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894632 (1989). 60 ancestors in all, the oldest K812810 (1981). No later device cites it as a predicate yet. 1 of the 61 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 6 generations between
- 3 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 2 generations backK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- 1 generation backK183525 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp. · 2019 · Recalled
- This deviceK260401 Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F…Olympus Medical Systems Corporation · 2026
Show all 10 generations
- Root · 10 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 9 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 8 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 7 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 6 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 5 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 4 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 3 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 2 generations backK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- 1 generation backK183525 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp. · 2019 · Recalled
- This deviceK260401 Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F…Olympus Medical Systems Corporation · 2026
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…5 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −9 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −8 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −7 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −6 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −5 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −4 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −2 | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | 3 |
| −1 | K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | 2019 | 1 |
| 0 (this device) | K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FSummary page 6…Device name 510(k) Submitter 510(k) No. EVIS EUS ULTRASOUND OLYMPUS MEDICAL SYSTEMS K183525 BRONCHOFIBERVIDEOSCOPE CORPORATION OLYMPUS BF-UC190F The Predicate device has not been subject to a design-related… | 2019 |
| † | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 15 of the 60 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K183525.
How does its category compare?
All PSV devicesPSV Ultrasound Bronchoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PSV
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PSV
Too few PSV 510(k)s in any year since 2007 to give a median.
Recalls per year · PSV
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSV
1,479in 2025
MAUDE reports naming product code PSV, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 37 |
| 2019 | 1 | — | 0 | 23 |
| 2020 | 0 | — | 0 | 149 |
| 2021 | 0 | — | 0 | 134 |
| 2022 | 0 | — | 0 | 367 |
| 2023 | 0 | — | 1 | 717 |
| 2024 | 0 | — | 0 | 627 |
| 2025 | 0 | — | 0 | 1,479 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, endoscopic therapy accessories such as an aspiration biopsy needle. The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle…
Read the full statement (87 words)
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, endoscopic therapy accessories such as an aspiration biopsy needle.
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways and tracheobronchial tree. It is intended for use in adult patients.
Operator qualifications:
Appropriately trained healthcare professionals
Device use settings:
Professional healthcare facility (no domestic or special environments)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260401: Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260401
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026