Shandong Zhushi Pharmaceutical Group Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Shandong Zhushi Pharmaceutical Group Co., Ltd.” (first 2021, latest 2024), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 162 days. Since 2017 the median was 162 days, against 142 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 |
|---|---|---|
| 2021 | 6 | 156 |
| 2022 | 1 | 414 |
| 2023 | 0 | — |
| 2024 | 1 | 268 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shandong Zhushi Pharmaceutical Group Co., Ltd. took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Shandong Zhushi Pharmaceutical Group Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232475 | Disposable infusion set with needle | FPA | 2024-05-10 | 268 |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | FMF | 2022-08-17 | 414 |
| K210510 | Disposable Surgical Gown | FYA | 2021-08-12 | 171 |
| K210643 | Disposable Surgical Face Mask | FXX | 2021-08-04 | 154 |
| K210409 | Disposable Surgical Face Mask | FXX | 2021-07-28 | 167 |
| K203454 | Infrared Thermometer | FLL | 2021-04-29 | 157 |
| K203436 | Disposable Nitrile Examination Gloves | LZA | 2021-04-28 | 156 |
| K203439 | Disposable Vinyl Examination Gloves | LYZ | 2021-02-26 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Shandong Zhushi Pharmaceutical Group 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.
- Shandong Huge Dental Material Corporation (9 510(k)s)
- Shandong Weigao Group Medical Polymer Co., Ltd. (7 510(k)s)
- Shandong Intco Medical Products Co, Ltd. (4 510(k)s)
- Shandong Xingyu Gloves Co., Ltd. (4 510(k)s)
- Shandong Blue Sail Innovation Co., Ltd. (3 510(k)s)
- Shandong Haidike Medical Products Co., Ltd. (3 510(k)s)
- Shandong Shengquan New Material Co., Ltd. (3 510(k)s)
- Shandong Haidike Medical Product Co., Ltd. (2 510(k)s)
- Shandong Hongxin Chemicals Co., Ltd. (2 510(k)s)
- Shandong Huamei Technology Co., Ltd. (2 510(k)s)
- Shandong Huayue Glove Co., Ltd. (2 510(k)s)
- Shandong Int Medical Instruments Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shandong Zhushi Pharmaceutical Group Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Shandong Zhushi Pharmaceutical Group Co., Ltd.” (first 2021, latest 2024), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shandong Zhushi Pharmaceutical Group Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shandong Zhushi Pharmaceutical Group Co., Ltd. is 162 days. Since 2017: 162 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shandong Zhushi Pharmaceutical Group Co., Ltd.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 2); FLL (Continuous Measurement Thermometer, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 8 Shandong Zhushi Pharmaceutical Group Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Shandong Zhushi Pharmaceutical Group 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.