510(k) · Cleared
ClearedEndoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Red Pine Medical Instrument Co., Ltd. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Jul 12, 2024 as substantially equivalent to K133538 (Olympus Corporation of the Americas, 2014) after a 45-day review. Its family tree reaches back 6 generations to 1993. 1 of the 22 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jul 12, 2024
- Review
- 45 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931154 (1993). 19 ancestors in all, the oldest K843084 (1985). 2 later devices descend from it, 2 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 4 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 3 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 2 generations backK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- 1 generation backK133538 Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera…Olympus Corporation of the Americas · 2014
- This deviceK241500 Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252176 Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243321 Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope4 generations back · 1991
Most influential descendants
Showing 2 of 2 · See all- K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025 · cites it directly0descendants
- K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −5 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −4 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −3 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −2 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| −1 | K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro… | Olympus Corporation of the Americas | 2014 | — |
| 0 (this device) | K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024 | — |
| +1 | K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025 | — |
| +1 | K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2025 | 2 | 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 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 |
|---|---|---|---|
| * | K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Summary page 5…r 876.1500 Product Code(s) FAJ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K133538 EVIS EXERA 11 180 System NWB Device Description Summary 21 CFR 807.92(a)(4) The proposed device, Cysto-Nephroscope System, which… | 2014 |
What descends from it? (2)
2 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.
- 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 31 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- 11 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252176 (Guangzhou Red Pine Medical Instrument Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K133538.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
Endoscopic Video Image Processor
This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope.
Single-Use Video Flexible Cysto-Nephroscope
This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
This product shall not be used for other purposes.
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/K241500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241500: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241500
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