Shanghai China Star Corp: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shanghai China Star Corp” (first 1999, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Shanghai China Star Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071072 | SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | LZA | 2007-08-30 | 136 |
| K010247 | SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES | LZA | 2001-02-06 | 11 |
| K003675 | SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES | LZA | 2001-01-09 | 41 |
| K992206 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | 1999-07-29 | 29 |
| K992205 | PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES | LYZ | 1999-07-23 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai China Star Corp.
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.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai China Star Corp?
FDA lists 5 510(k) clearances under the applicant name “Shanghai China Star Corp” (first 1999, latest 2007), across 2 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 Shanghai China Star Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai China Star Corp is 29 days.
Which FDA product codes appear under Shanghai China Star Corp?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 3); LYZ (Vinyl Patient Examination Glove, 2).
Next steps
- See all 5 Shanghai China Star Corp clearances with predicates and recalls
- Run predicate analysis for product code LZA, Shanghai China Star Corp'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.