510(k) · Cleared
Recalled · Class II · 2023Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System
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 Jul 5, 2007 as substantially equivalent to K042140 (Olympus Corporation, 2004) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1989. 1 of the 70 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 5, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- PSV
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894632 (1989). 58 ancestors in all, the oldest K812810 (1981). 11 later devices descend from it, 3 citing it directly. 1 of the 70 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 6 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 5 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 4 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 3 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 2 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 1 generation backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- This deviceK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007
- Descendant · cites it directly · 5 of its ownK081518 Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008
- Descendant · 2 generations on · 3 of its ownK131946 Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK183525 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK203128 Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus…Olympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 1 of its ownK183516 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…3 generations back · 2003
Most influential descendants
Showing 5 of 11 · See all- K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008 · cites it directly5descendants
- K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · 2 generations on3descendants
- K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp. · 2019 · cites it directly2descendants
- K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp. · 2020 · cites it directly1descendant
- K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −7 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −6 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −5 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −4 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −3 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −2 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −1 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| 0 (this device) | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | — |
| +1 | K081518 | Ultrasound Video Bronchoscope, Model EB-1970UK | Pentax Medical Company | 2008 | — |
| +2 | K131946 | Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus | Pentax Medical Company | 2014 | 4 |
| +1 | K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | 2019 | 1 |
| +1 | K203128 | Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic… | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 PSV device
- #1 K260401 Evis Eus Ultrasound Bronchofibervideoscope…score 14.6 · 10 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K042140 | Olympus BF Type UC160-OL8Summary page 6…0-1TX/78-KOG/90IYN 3 _Predicate Device !nf_qv rmation R Ulfrasonic Endoscope Subject device Predicate devige ‘ Name I | Control humber XBF-UC180F-DT8 BF-UC160F-OL8 ;1 K042140 ULTRASONIC EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE SSD-Alpha 5 ALOKA SSD-ALPHA 5 K041916 ULTRASOUND… | 2004 |
| * | K041916 | Aloka SSD-Alpha 5 Ultrasound SystemSummary page 6…I | Control humber XBF-UC180F-DT8 BF-UC160F-OL8 ;1 K042140 ULTRASONIC EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE SSD-Alpha 5 ALOKA SSD-ALPHA 5 K041916 ULTRASOUND SYSTEM SSD-Alpha 10 ALOKA SSD-ALPHA 10 K043196 ULTRASOUND SYSTEM 4 Device Degcription OLYMPUS XBF- UC180F-DT8 ULTRAS… | 2004 |
| * | K043196 | Aloka SSD-Alpha 10 Ultrasound SystemSummary page 6…ULTRASONIC EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE | BRONCHOFIBERVIDEOSCOPE SSD-Alpha 5 ALOKA SSD-ALPHA 5 K041916 ULTRASOUND SYSTEM SSD-Alpha 10 ALOKA SSD-ALPHA 10 K043196 ULTRASOUND SYSTEM 4 Device Degcription OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE has been designed to be used w… | 2004 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0328-2024 | 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-2494-2023 | 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-3304-2018 | 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 13 of the 58 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K081518 (Pentax Medical Company, 2008) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K042140.
How does its category compare?
All PSV devicesPSV Ultrasound Bronchoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal(non-cardiac)
Airways and tracheobronchial tree
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal(non-cardiac)
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/K070983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070983
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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