510(k) · Cleared
ClearedVisera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Aug 30, 2019 as substantially equivalent to K111425 (Olympus Medical Systems Corp., 2012) and 1 other predicate after a 186-day review. Its family tree reaches back 9 generations to 1993. 3 of the 39 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Aug 30, 2019
- Review
- 186 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931154 (1993). 33 ancestors in all, the oldest K843084 (1985). 5 later devices descend from it, 3 citing it directly. 3 of the 39 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 backK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · Recalled
- This deviceK190449 Visera Elite II Video System Center, Visera Elite II HD 3CMOS…Olympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 2 of its ownK242067 Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite…Olympus Corporations of the Americas · 2025
- Descendant · 2 generations on · 0 of its ownK262079 4K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026
- Descendant · cites it directly · 0 of its ownK261260 HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)…Olympus Medical Systems Corp. · 2025
- Descendant · cites it directly · 0 of its ownK200542 Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra…Olympus 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 backK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · Recalled
- This deviceK190449 Visera Elite II Video System Center, Visera Elite II HD 3CMOS…Olympus Medical Systems Corp. · 2019
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas · 2025 · cites it directly2descendants
- K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026 · 2 generations on0descendants
- K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation · 2026 · cites it directly0descendants
- K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp. · 2025 · 2 generations on0descendants
- K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp. · 2020 · cites it directly0descendants
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 | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | Olympus Medical Systems Corp. | 2012 | 1 |
| 0 (this device) | K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable… | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K242067 | Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led… | Olympus Corporations of the Americas | 2025 | — |
| +2 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | 2026 | — |
| +1 | K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | 2026 | — |
| +2 | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE… | Olympus Medical Systems Corp. | 2025 | — |
| +1 | K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite… | 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 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Summary page 6…510(k) No. VISERA ELITE VIDEO SYSTEM CENTER K111425 VISERA ELITE II VIDEO OLYMPUS OTV-S190 SYSTEM CENTER OLYMPUS OTV-S200 VISERA ELITE… | 2012 |
| * | K102059 | Autoclavable Camer Head Model Otv-Y0017Summary page 6…510(k) No. VISERA ELITE II HD 3CMOS AUTOCLAVABLE AUTOCLAVABLE CAMERA K102059 CAMERA HEAD HEAD OTV-Y0017 OLYMPUS CH-S200-XZ-EA VISERA ELITE II HD AUTOCLAVABLE CAMERA… | 2010 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 17 of the 33 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K242067 (Olympus Corporations of the Americas, 2025) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K111425.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190449: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190449
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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