Guangzhou Red Pine Medical Instrument Co., Ltd.: FDA clearances and approvals
Guangzhou Red Pine Medical Instrument Co., Ltd. has 10 FDA 510(k) clearances (first 2023, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time: 106 days. Since 2017 its median was 106 days, against 137 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 319 |
| 2024 | 5 | 105 |
| 2025 | 3 | 107 |
| 2026 | 1 | 51 |
Review time against the same product codes
Since 2017, Guangzhou Red Pine Medical Instrument Co., Ltd.'s cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 3 | 3 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 3 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Guangzhou Red Pine Medical Instrument Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | FGB | 2026-09-09 | 51 |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) | FGB | 2025-12-16 | 174 |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | FAJ | 2025-08-08 | 28 |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | FET | 2025-02-07 | 107 |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | HIH | 2024-08-02 | 25 |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | FAJ | 2024-07-12 | 45 |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | FAJ | 2024-06-21 | 105 |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | FDF | 2024-02-16 | 221 |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | HIH | 2024-02-12 | 221 |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | FGB | 2023-03-06 | 319 |
Recalls
openFDA lists no recalls under a recalling firm named Guangzhou Red Pine Medical Instrument Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Guangzhou Red Pine Medical Instrument Co., Ltd. have?
Guangzhou Red Pine Medical Instrument Co., Ltd. has 10 FDA 510(k) clearances (first 2023, latest 2026), across 5 product codes in 2 review panels.
How long does FDA take to clear Guangzhou Red Pine Medical Instrument Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Guangzhou Red Pine Medical Instrument Co., Ltd.'s cleared 510(k)s is 106 days. Since 2017: 106 days, versus 137 days for all cleared 510(k)s in the same product codes.
What devices does Guangzhou Red Pine Medical Instrument Co., Ltd. make?
Its most frequent FDA product codes are FAJ (Cystoscope And Accessories, Flexible/Rigid, 3); FGB (Ureteroscope And Accessories, Flexible/Rigid, 3); HIH (Hysteroscope (And Accessories), 2).
Has Guangzhou Red Pine Medical Instrument Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Guangzhou Red Pine Medical Instrument Co., Ltd. Related entities may recall under other names.
Next steps
- See all 10 Guangzhou Red Pine Medical Instrument Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FAJ, Guangzhou Red Pine Medical Instrument Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.