Shandong Weigao Group Medical Polymer Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Shandong Weigao Group Medical Polymer Co., Ltd.” (first 2007, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 178 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 178 |
| 2023 | 1 | 616 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shandong Weigao Group Medical Polymer Co., Ltd. took a median 397 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
Review panels
Most recent Shandong Weigao Group Medical Polymer Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212207 | Sterile Hypodermic Syringe for Single Use | FMF | 2023-03-23 | 616 |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use | FMF | 2022-03-11 | 178 |
| K102741 | ENTERAL FEEDING BAG AND SETS | KNT | 2011-11-08 | 412 |
| K102328 | BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA | FMI | 2011-05-13 | 269 |
| K081241 | WEIGAO EMPTY CARTRIDGE SYRINGE | FMF | 2008-09-08 | 130 |
| K072739 | JIERUI SYRINGES AND NEEDLES | MEG | 2008-03-21 | 176 |
| K073127 | BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G | FMI | 2007-12-20 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Shandong Weigao Group Medical Polymer 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 Zhushi Pharmaceutical Group Co., Ltd. (8 510(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 Weigao Group Medical Polymer Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Shandong Weigao Group Medical Polymer Co., Ltd.” (first 2007, latest 2023), across 4 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 Shandong Weigao Group Medical Polymer Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shandong Weigao Group Medical Polymer Co., Ltd. is 178 days.
Which FDA product codes appear under Shandong Weigao Group Medical Polymer Co., Ltd.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 3); FMI (Needle, Hypodermic, Single Lumen, 2); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 7 Shandong Weigao Group Medical Polymer Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Shandong Weigao Group Medical Polymer 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.