Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

144 daysmedian FDA review time
257 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K234024HWJECT Auto-disable syringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2024-03-19900
K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-11-303250
K230043Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-09-202570
K223323Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-03-241440
K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-11-041090
K222141Safety Blood Collection Needle (Without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-10-21930
K220900Safety Blood Collection Needles with/without Needle HolderAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-08-101350
K220083LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-05-251350
K214075Safety Blood Collection / Infusion Set (with/without needle Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-04-121060
K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyriAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2021-10-181520
K202188Safety Blood Collection Sets for Single UseAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2021-02-191990
K190183Hypodermic Safety Needle, Hypodermic Safety Needle with SyriAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2019-10-042450

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