510(k) · Cleared
ClearedUltrathin Ureteroscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Aug 16, 1995 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 29 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it.
- Decided
- Aug 16, 1995
- Review
- 117 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.
- This deviceK951855 Ultrathin UreteroscopesOlympus America, Inc. · 1995
- Descendant · cites it directly · 26 of its ownK033651 Olympus Video Ureteroscope, NTSCOlympus Winter & Ibe GmbH · 2004
- Descendant · 2 generations on · 24 of its ownK153049 LithoVue SystemBoston Scientific Corporation · 2015
- Descendant · 3 generations on · 9 of its ownK180367 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018
- Descendant · 3 generations on · 4 of its ownK221515 StoneSmart Connect Console, LithoVue Elite Single Use Digital…Boston Scientific Corporation · 2023
- Descendant · 4 generations on · 4 of its ownK201293 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2020
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor4 generations on · 2024
Most influential descendants
Showing 5 of 28 · See all- K033651Olympus Video Ureteroscope, NTSCOlympus Winter & Ibe GmbH · 2004 · cites it directly26descendants
- K153049LithoVue SystemBoston Scientific Corporation · 2015 · 2 generations on24descendants
- K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018 · 3 generations on9descendants
- K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation · 2023 · 3 generations on4descendants
- K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2020 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951855 | Ultrathin Ureteroscopes | Olympus America, Inc. | 1995 | — |
| +1 | K033651 | Olympus Video Ureteroscope, NTSC | Olympus Winter & Ibe GmbH | 2004 | — |
| +2 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| +3 | K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018 | — |
| +3 | K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible… | Boston Scientific Corporation | 2023 | — |
| +4 | K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 1 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K033651 (Olympus Winter & Ibe GmbH, 2004) has gone furthest, with 26 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.
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 | — |
https://510kreport.com/device/K951855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951855: Ultrathin Ureteroscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951855
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026