510(k) · Cleared
ClearedUltrasound Video Bronchoscope, Model EB-1970UK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical Company · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Sep 5, 2008 as substantially equivalent to K070983 (Olympus Medical Systems Corporation, 2007) and 2 other predicates after a 98-day review. Its family tree reaches back 9 generations to 1989. 1 of the 68 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894632 (1989). 62 ancestors in all, the oldest K812810 (1981). 5 later devices descend from it, 2 citing it directly. 1 of the 68 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 5 generations between
- 3 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 2 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 1 generation backK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- This deviceK081518 Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008
- Descendant · cites it directly · 3 of its ownK131946 Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK183516 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK203166 PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX…Pentax of America, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK183654 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi…Pentax of America, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK173554 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video…Pentax of America, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 8 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 7 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 6 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 5 generations backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- 4 generations backK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- 3 generations backK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- 2 generations backK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- 1 generation backK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
- This deviceK081518 Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…4 generations back · 2003
Most influential descendants
Showing 5 of 5 · See all- K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · cites it directly3descendants
- K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc. · 2019 · 2 generations on1descendant
- K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc. · 2020 · 3 generations on0descendants
- K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc. · 2019 · 2 generations on0descendants
- K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −8 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −7 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −6 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −5 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| −4 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| −3 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| −2 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| −1 | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | 3 |
| 0 (this device) | 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 |
| +2 | K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | 2019 | — |
| +3 | K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical… | Pentax of America, Inc. | 2020 | — |
| +2 | K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI… | Pentax of America, Inc. | 2019 | — |
| +1 | K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video… | Pentax of America, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Summary page 1…Manufacturer PMN # BF type UC-160F, Ultrasound Brochofiberscope Olympus K070983 EB- 1830T3, Video Bronchoscope Pentax K023376 EUB-5500 Diagnostic… | 2007 |
| * | K023376 | EB-1830T3, Video BronchoscopeSummary page 1…pe Olympus K070983 EB- 1830T3, Video Bronchoscope Pentax K023376 EUB-5500 Diagnostic Ultrasound Scanner Hitachi K063518 Device Description… | 2002 |
| * | K063518 | HI Vision 900 Diagnostic Ultrasound ScannerSummary page 1…Pentax K023376 EUB-5500 Diagnostic Ultrasound Scanner Hitachi K063518 Device Description: The EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software control… | 2006 |
What descends from it? (5)
2 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)
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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 62 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131946 (Pentax Medical Company, 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K070983.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Diagnostic Ultrasound imaging or fluid flow analysis of the human body
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081518: Ultrasound Video Bronchoscope, Model EB-1970UK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081518
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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