510(k) · Cleared
ClearedVisera 4K Uhd System
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 Oct 1, 2015 as substantially equivalent to K111425 (Olympus Medical Systems Corp., 2012) and 1 other predicate after a 169-day review. Its family tree reaches back 9 generations to 1993. 3 of the 37 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Oct 1, 2015
- Review
- 169 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931154 (1993). 33 ancestors in all, the oldest K843084 (1985). 3 later devices descend from it, 3 citing it directly. 3 of the 37 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 deviceK151011 Visera 4K Uhd SystemOlympus Medical Systems Corp. · 2015
- Descendant · cites it directly · 0 of its ownK250551 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200216 4K UHD Camera SystemScivita Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK172817 4K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head…Olympus Medical Systems Corp. · 2017
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 deviceK151011 Visera 4K Uhd SystemOlympus Medical Systems Corp. · 2015
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd. · 2025 · cites it directly0descendants
- K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd. · 2020 · cites it directly0descendants
- K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp. · 2017 · 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) | K151011 | Visera 4K Uhd System | Olympus Medical Systems Corp. | 2015 | — |
| +1 | K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | 2025 | — |
| +1 | K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020 | — |
| +1 | K172817 | 4K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus… | Olympus Medical Systems Corp. | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (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 5…510(k) No. VISERA 4K UHD VISERA ELITE CAMERA CONTROL UNIT VIDEO SYSTEM CENTER K111425 OLYMPUS OTV-S400 OLYMPUS OTV-S190 VISERA 4K UHD VISERA ELITE XENON LIGHT SOURCE… | 2012 |
| * | K102059 | Autoclavable Camer Head Model Otv-Y0017Summary page 5…OLYMPUS CLV-S190 AUTOCLAVABLE CAMERA 4K CAMERA HEAD HEAD K102059 OLYMPUS CH-S400-XZ-EB OTV-Y0017 IV. Device Description The VISERA 4K Ultra-High… | 2010 |
What descends from it? (3)
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 22 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, K250551 (Shenzhen Sophway Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K111425.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400 The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400 The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic…
Read the full statement (102 words)
VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400
The camera control unit has been designed to be used with Olympus endoscopes, camera heads, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
VISERA 4K UHD XENON LIGHT SOURCE OLYMPUS CLV-S400
The light source has been designed to be used with Olympus endoscopes, camera control unit, light guide cables, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151011: Visera 4K Uhd System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151011
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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