Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.” (first 2019, latest 2024), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 140 days. Since 2017 the median was 140 days, against 175 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 245 |
| 2020 | 0 | — |
| 2021 | 2 | 176 |
| 2022 | 5 | 109 |
| 2023 | 3 | 257 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| MEG | Syringe, Antistick | 2 | 2 |
| QNQ | Low Dead Space Piston Syringe | 1 | 1 |
Review panels
Most recent Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234024 | HWJECT Auto-disable syringe | FMF | 2024-03-19 | 90 |
| K230061 | Insulin Syringe | FMF | 2023-11-30 | 325 |
| K230043 | Insulin Pen Needle | FMI | 2023-09-20 | 257 |
| K223323 | Blood Collection Needle (with/without Needle Holder) | JKA | 2023-03-24 | 144 |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | FMI | 2022-11-04 | 109 |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | JKA | 2022-10-21 | 93 |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | JKA | 2022-08-10 | 135 |
| K220083 | LDV((Low Dead Volume )Syringe | QNQ | 2022-05-25 | 135 |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | FMI | 2022-04-12 | 106 |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | MEG | 2021-10-18 | 152 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Anhui Tiankang Medical Technology Co., Ltd. (12 510(k)s)
- Anhui Jbh Medical Apparatus Co., Ltd. (10 510(k)s)
- Anhui Intco Medical Products Co., Ltd. (4 510(k)s)
- Anhui Kindguard Medical Supplies Technology Co., Ltd. (3 510(k)s)
- Anhui Powerguard Technology Co., Ltd. (3 510(k)s)
- Anhui Anyu Latex Products Co., Ltd. (2 510(k)s)
- Anhui Bytech Medical Supplies Co., Ltd. (2 510(k)s)
- Anhui Deepblue Medical Technology Co., Ltd. (2 510(k)s)
- Anhui Kangda Medical Products Co., Ltd. (2 510(k)s)
- Anhui Longway Medical Technology Co., Ltd. (2 510(k)s)
- Anhui Xinyisheng Medical Technology Co.,Ltd (2 510(k)s)
- Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.” (first 2019, latest 2024), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. is 140 days. Since 2017: 140 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 4); FMI (Needle, Hypodermic, Single Lumen, 3); FMF (Syringe, Piston, 2).
Next steps
- See all 12 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.