510(k) · Cleared
ClearedOlympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190
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 Mar 1, 2013 as substantially equivalent to K102379 (Olympus Medical Systems Corporation, 2011) and 2 other predicates after a 121-day review. Its family tree reaches back 9 generations to 1993. 3 of the 56 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.
- Decided
- Mar 1, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K931154 (1993). 36 ancestors in all, the oldest K843084 (1985). 19 later devices descend from it, 6 citing it directly. 3 of the 56 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- This deviceK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- Descendant · cites it directly · 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 · 2 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
- Descendant · 3 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK201200 Visera Elite II Video System CenterOlympus Medical Systems Corp. · 2020
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 5 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 4 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- This deviceK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 19 · See all- K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc. · 2015 · cites it directly7descendants
- K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America · 2020 · 2 generations on5descendants
- K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020 · cites it directly5descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 3 generations on4descendants
- K201200Visera Elite II Video System CenterOlympus Medical Systems Corp. · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −5 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −4 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −1 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| 0 (this device) | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
| +1 | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015 | — |
| +2 | 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 | — |
| +3 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
| +2 | K201200 | Visera Elite II Video System Center | 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 | 5 | 0 |
| 1996 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 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.
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? (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 |
|---|---|---|---|
| * | K102379 | LTF-Y0009; Maj-YOO41; Xoev-3D1Summary page 2…. . . .Predicate De e *P' OLYMPUS LTF-1 90-1 0-30 LTF-YO009 K1 02379 ENDOEYE FLEX 3D DEFLECTABLE 3D Laparo-Thoraco Videoscope VIDEOSCOPE (Hereinafter referred to as L… | 2011 |
| * | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Summary page 2…3D Laparo-Thoraco Videoscope VIDEOSCOPE (Hereinafter referred to as LTF-1 90-10-3D) LTF-5190-10 K111425 ENDOEYE FLEX DEFLECTABLE… | 2012 |
| * | K112680 | Evis Exera Iii Video SystemSummary page 2…3D Video Mixer (Hereinafter referred to as MAJ-Y0 154) OLYMPUS CV-190 CV-190 K112680 EVIS EXERA III VIDEO SYSTEM CENTER EVIS EXERA Ill VIDEO SYSTEM (Hereinafter referred to as CV-1 90)… | 2012 |
| † | K113203 | Sony LMD-2451MT LCD Monitor | 2012 |
What descends from it? (19)
See all 196 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | 2015 | 7 |
| K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | 2020 | 5 |
| K221642 | SIRIUS Endoscope System | 2022 | 1 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | 2021 | 0 |
| K183675 | 3D Visualization System | 2019 | 0 |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | 2018 | 0 |
Has anything in its family been recalled? (3 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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations back · ◆ 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 36 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K150525 (KARL STORZ Endoscopy-America, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K102379.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact…
Read the full statement (146 words)
This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs.
This instrument must not 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 3D processor is intended to be used with 3D videoscope and video system center for 3D observation
This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123365
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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