510(k) · Cleared
Recalled · Class II · 2023Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Jan 16, 2019 as substantially equivalent to K172246 (Olympus Medical Systems Corp., 2018) and 1 other predicate after a 229-day review. Its family tree reaches back 5 generations to 1986. 1 of the 13 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 16, 2019
- Review
- 229 days
- Class
- Class II
- Product code
- FGB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K853585 (1986). 11 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 4 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 3 generations backK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · Recalled
- 2 generations backK072957 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2008 · Recalled
- 1 generation backK172246 Olympus Urf-V2/V2ROlympus Medical Systems Corp. · 2018 · Recalled
- This deviceK181451 Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope…Olympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 0 of its ownK191078 BAROnova Access Sheath KitBaronova, Inc. · 2019
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope2 generations back · 1991
Most influential descendants
Showing 1 of 1 · See all- K191078BAROnova Access Sheath KitBaronova, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −4 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −3 | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | 3 |
| −2 | K072957 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2008 | 1 |
| −1 | K172246 | Olympus Urf-V2/V2R | Olympus Medical Systems Corp. | 2018 | 3 |
| 0 (this device) | K181451 | Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus… | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K191078 | BAROnova Access Sheath Kit | Baronova, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 1 |
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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.
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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 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 |
|---|---|---|---|
| * | K172246 | Olympus Urf-V2/V2RSummary page 5…Device name 510(k) Submitter 510(k) No. OLYMPUS URF-V2/V2R OLYMPUS MEDICAL SYSTEMS CORP. K172246 URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R Table 5-2 Predicate device Device name 510(k) Submitter… | 2018 |
| * | K172298 | Olympus Urf-P6/P6RSummary page 5…Device name 510(k) Submitter 510(k) No. OLYMPUS URF-P6/P6R OLYMPUS MEDICAL SYSTEMS CORP. K172298 5.4 DEVICE DESCRIPTION URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URF-V3 and URF-V3R have been designed to be used with an Oly… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191078 | BAROnova Access Sheath Kit | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0348-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
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 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- 9 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191078 (Baronova, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
-OLYMPUS URF-V3/V3R
This instrument has 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 ureter and kidney.
-OLYMPUS URF-P7/P7R
This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181451: Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181451
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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