510(k) · Cleared
Recalled · Class II · 2023Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Apr 20, 2012 as substantially equivalent to K080948 (Olympus Medical Systems Corporation, 2008) and 3 other predicates after a 333-day review. Its family tree reaches back 8 generations to 1993. 3 of the 64 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it. It has been recalled once.
- Decided
- Apr 20, 2012
- Review
- 333 days
- Class
- Class II
- Product code
- HET
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931154 (1993). 29 ancestors in all, the oldest K843084 (1985). 34 later devices descend from it, 6 citing it directly. 3 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 4 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 3 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 2 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 1 generation backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- This deviceK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012
- Descendant · cites it directly · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- Descendant · 2 generations on · 7 of its ownK150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU…KARL STORZ Endoscopy-America, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light…Stryker · 2023
- Descendant · 3 generations on · 5 of its ownK201526 TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America · 2020
- Descendant · cites it directly · 5 of its ownK193026 Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · cites it directly19descendants
- K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc. · 2015 · 2 generations on7descendants
- K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker · 2023 · cites it directly5descendants
- K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America · 2020 · 3 generations on5descendants
- K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −4 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −3 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −2 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −1 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| 0 (this device) | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | Olympus Medical Systems Corp. | 2012 | — |
| +1 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
| +2 | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015 | — |
| +1 | K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source… | Stryker | 2023 | — |
| +3 | K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy America | 2020 | — |
| +1 | K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | Olympus Medical Systems Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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.
3 devices in this family have 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 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? (4)
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 |
|---|---|---|---|
| * | K080948 | HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH | 2008 |
| * | K061313 | Evis Exera 180 SystemSummary page 2…anishi, Ooaza-lidera, LTF Type VH Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595 OLYMPUS CLV-S190 EVIS EXERA Il XENON | K061313 SHIRAKAWA VISERA ELITE XENON | LIGHT SOURCE | K062049 OLYMPUS CO., LTD. LIGHT SOURCE OLYMPUS CLV-180 31, Aza-Ookamiyama, OLYMPUS… | 2006 |
| * | K062049 | Evis Exera II 180 SystemSummary page 2…matsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595 OLYMPUS CLV-S190 EVIS EXERA Il XENON | K061313 SHIRAKAWA VISERA ELITE XENON | LIGHT SOURCE | K062049 OLYMPUS CO., LTD. LIGHT SOURCE OLYMPUS CLV-180 31, Aza-Ookamiyama, OLYMPUS OTV-S190 EVIS EXERA Il XENON | K061313 Ooaza-Odakura,… | 2006 |
| * | K100584 | Evis Exeraii 180 SystemSummary page 2…1, Aza-Ookamiyama, OLYMPUS OTV-S190 EVIS EXERA Il XENON | K061313 Ooaza-Odakura, VISERA ELITE VIDEO | LIGHT SOURCE | K062049 Nishigo-mura, SYSTEM CENTER OLYMPUS CV-180 K100584 Nishishirakawa-gun, ) ' Fukushima, Japan 961-8061 Establishment Registration No: 3002808148 2/5 : BB 1 4 Device… | 2010 |
What descends from it? (34)
See all 346 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | 2013 | 19 |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | 2023 | 5 |
| K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | 2020 | 5 |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head… | 2019 | 5 |
| K151011 | Visera 4K Uhd System | 2015 | 3 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control… | 2021 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2023 | Class II | Z-0645-2024 | Labeling Change Control | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes |
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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 16 of the 29 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K123365 (Olympus Medical Systems Corp., 2013) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K080948.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with a video system center, light source, dlocumentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. This instrument must not to be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In…
Read the full statement (149 words)
This instrument has been designed to be used with a video system center, light source, dlocumentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
This instrument must not to be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
This video system center has been designed to be used with OLYMPUS camera heads, endloscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
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/K111425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111425
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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