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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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-UGuangzhou Red Pine Medical Instrument Co., Ltd.2025-12-161740
K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-UGuangzhou Red Pine Medical Instrument Co., Ltd.2025-08-08280
K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.2025-02-071070
K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-08-02250
K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-UsGuangzhou Red Pine Medical Instrument Co., Ltd.2024-07-12450
K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201SGuangzhou Red Pine Medical Instrument Co., Ltd.2024-06-211050
K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V200Guangzhou Red Pine Medical Instrument Co., Ltd.2024-02-162210
K232003Endoscopic Video Image Processor, Single-Use Video HysteroscGuangzhou Red Pine Medical Instrument Co., Ltd.2024-02-122210
K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd.2023-03-063190

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