510(k) · Cleared
ClearedVisera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corporation of the Americas · NWB Endoscope, Accessories, Narrow Band Spectrum
Cleared on Aug 7, 2014 as substantially equivalent to K062049 (Olympus Medical Systems Corporation, 2006) after a 262-day review. Its family tree reaches back 5 generations to 1993. 1 of the 44 devices in its family, counting itself, has a Class I recall. 25 later devices descend from it.
- Decided
- Aug 7, 2014
- Review
- 262 days
- Class
- Class II
- Product code
- NWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931154 (1993). 18 ancestors in all, the oldest K843084 (1985). 25 later devices descend from it, 5 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 2 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 1 generation backK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- This deviceK133538 Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera…Olympus Corporation of the Americas · 2014
- Descendant · cites it directly · 14 of its ownK160766 Ambu USR, Ambu MAmbu A/S · 2016
- Descendant · 2 generations on · 13 of its ownK193095 Ambu aScope 4 CystoAmbu A/S · 2020
- Descendant · cites it directly · 3 of its ownK182723 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK241500 Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK191357 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope3 generations back · 1991
Most influential descendants
Showing 5 of 25 · See all- K160766Ambu USR, Ambu MAmbu A/S · 2016 · cites it directly14descendants
- K193095Ambu aScope 4 CystoAmbu A/S · 2020 · 2 generations on13descendants
- K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · cites it directly3descendants
- K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2024 · cites it directly2descendants
- K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −2 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −1 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| 0 (this device) | K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro… | Olympus Corporation of the Americas | 2014 | — |
| +1 | K160766 | Ambu USR, Ambu M | Ambu A/S | 2016 | — |
| +2 | K193095 | Ambu aScope 4 Cysto | Ambu A/S | 2020 | — |
| +1 | K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| +1 | K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024 | — |
| +2 | K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 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 NWB device
- #1 K211882 HD-550 Video Endoscope Systemscore 8.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K062049 | Evis Exera II 180 SystemSummary page 4…arrow band spectrum) FAJ (cystoscope and accessories, flexible/rigid ) 3. Predicate Devices EVIS EXERA II 180 SYSTEM (K062049) Section6 510(k) Summary Page 2 of 4… | 2006 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160766 | Ambu USR, Ambu M | 2016 | 14 |
| K182723 | Flexible HD Cysto-Urethroscope System | 2019 | 3 |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible… | 2024 | 2 |
| K221683 | CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)… | 2023 | 1 |
| K221690 | Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)… | 2022 | 0 |
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.
- 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 21 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 11 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160766 (Ambu A/S, 2016) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K062049.
How does its category compare?
All NWB devicesNWB Endoscope, Accessories, Narrow Band Spectrum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NWB
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NWB
Too few NWB 510(k)s in any year since 2007 to give a median.
Recalls per year · NWB
5in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NWB
2,847in 2025
MAUDE reports naming product code NWB, 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 | 2 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 1 | — | 3 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 823 |
| 2021 | 0 | — | 0 | 1,453 |
| 2022 | 2 | — | 0 | 1,828 |
| 2023 | 0 | — | 5 (2) | 2,180 |
| 2024 | 0 | — | 0 | 2,648 |
| 2025 | 0 | — | 0 | 2,847 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 : This video system center has been designed to be…
Read the full statement (126 words)
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R :
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 :
This video system center has been designed 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.
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 :
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 as stated in the FDA summary.
https://510kreport.com/device/K133538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133538: Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133538
Report an extraction error
Are you the manufacturer?
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