Shina Med Corporation: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Shina Med Corporation” (first 2016, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 236 days. Since 2017 the median was 185 days, against 174 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 |
|---|---|---|
| 2016 | 2 | 298 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 88 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 344 |
| 2023 | 1 | 185 |
| 2024 | 0 | — |
| 2025 | 2 | 132 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shina Med Corporation took a median 185 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| MEG | Syringe, Antistick | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Shina Med Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250510 | Sure-Fine Insulin Syringes | FMF | 2025-10-15 | 236 |
| K250658 | SureFine Pen Needle | FMI | 2025-04-03 | 29 |
| K231165 | Shina Syringe; Shina Safety Syringe | MEG | 2023-10-27 | 185 |
| K210848 | Sure-Fine Insulin Syringes | FMF | 2022-03-01 | 344 |
| K191531 | Sure-Fine Insulin Syringes | FMF | 2019-09-06 | 88 |
| K152879 | Sure-Fine Insulin Syringes | FMF | 2016-09-09 | 345 |
| K152877 | SureFine Pen Needle | FMI | 2016-06-07 | 251 |
Recalls
openFDA lists no recalls under a recalling firm named Shina Med Corporation.
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.
- Shina Corp. (4 510(k)s)
- Shina Systems , Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shina Med Corporation?
FDA lists 7 510(k) clearances under the applicant name “Shina Med Corporation” (first 2016, latest 2025), across 3 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 Shina Med Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shina Med Corporation is 236 days. Since 2017: 185 days, versus 174 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shina Med Corporation?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 4); FMI (Needle, Hypodermic, Single Lumen, 2); MEG (Syringe, Antistick, 1).
Next steps
- See all 7 Shina Med Corporation clearances with predicates and recalls
- Run predicate analysis for product code FMF, Shina Med Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.