510(k) · Cleared
ClearedSingle-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Red Pine Medical Instrument Co., Ltd. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Sep 9, 2026 as substantially equivalent to K251951 (Guangzhou Red Pine Medical Instrument Co., Ltd., 2025) after a 51-day review. Its family tree reaches back 11 generations to 1993. 1 of the 28 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 9, 2026
- Review
- 51 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931154 (1993). 27 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- 2 generations backK221158 Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd. · 2023
- 1 generation backK251951 Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025
- This deviceK262488 Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 7 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 6 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 5 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 4 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 3 generations backK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- 2 generations backK221158 Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd. · 2023
- 1 generation backK251951 Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025
- This deviceK262488 Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2026
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope9 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −7 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −6 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −5 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −4 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −3 | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| −2 | K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023 | — |
| −1 | K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025 | — |
| 0 (this device) | K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Summary page 5…: 21 CFR 876.1500 Classification Name: Ureteroscope and accessories, flexible/rigid Product Code: FGB III. Legally Marketed Predicate Device Predicate 510(k) Number: K251951 Device name: Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U- C03S9, RP-U-C03S3); Product Code: FGB No… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 9 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 7 companies; a new generation was cleared every 2.8 years on median.
- 8 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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?
The device has been developed to be used with endoscopic accessories and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262488: Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262488
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026