510(k) · Cleared
ClearedPENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on May 23, 2019 as substantially equivalent to K131946 (Pentax Medical Company, 2014) after a 147-day review. Its family tree reaches back 11 generations to 1989. 1 of the 65 devices in its family, counting itself, has a Class I recall.
- Decided
- May 23, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894632 (1989). 64 ancestors in all, the oldest K812810 (1981). No later device cites it as a predicate yet. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 7 generations between
- 3 generations backK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- 2 generations backK081518 Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008
- 1 generation backK131946 Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · Recalled
- This deviceK183654 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi…Pentax of America, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 10 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 9 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 8 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 7 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 6 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 5 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 4 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 3 generations backK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- 2 generations backK081518 Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008
- 1 generation backK131946 Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · Recalled
- This deviceK183654 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi…Pentax of America, Inc. · 2019
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…6 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −10 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −9 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −8 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −7 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −6 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −5 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −3 | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | 3 |
| −2 | K081518 | Ultrasound Video Bronchoscope, Model EB-1970UK | Pentax Medical Company | 2008 | — |
| −1 | K131946 | Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus | Pentax Medical Company | 2014 | 4 |
| 0 (this device) | K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI… | 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 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 1 |
| 2004 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K131946 | Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusSummary page 4…Bronchoscope Name of the System: PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus EB-1970UK with EPK-i5010 Video Processor (K131946), EPK-i7010 Video Processor (K173679) plus HI VISION Preirus Ultrasound Scanner (K093466) and NOBLUS Ultrasound Diagnostic System… | 2014 |
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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 16 of the 64 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K131946.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183654: PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183654
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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