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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2024-03-19 | 90 | 0 |
| K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-11-30 | 325 | 0 |
| K230043 | Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 | 257 | 0 |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-03-24 | 144 | 0 |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic N | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-11-04 | 109 | 0 |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-10-21 | 93 | 0 |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-08-10 | 135 | 0 |
| K220083 | LDV((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-05-25 | 135 | 0 |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-04-12 | 106 | 0 |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syri | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-10-18 | 152 | 0 |
| K202188 | Safety Blood Collection Sets for Single Use | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-02-19 | 199 | 0 |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syri | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2019-10-04 | 245 | 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