Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangzhou Red Pine Medical Instrument Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
319 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 | 174 | 0 |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 | 28 | 0 |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-02-07 | 107 | 0 |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 | 25 | 0 |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Us | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-07-12 | 45 | 0 |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-06-21 | 105 | 0 |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V200 | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-16 | 221 | 0 |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysterosc | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-12 | 221 | 0 |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023-03-06 | 319 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda