# Shina Med Corporation

- Location (FDA's records): Anseong-Si, KR
- FDA decisions: 7 (2016–2025): 7 510(k) clearances
- Product codes: FMF (4), FMI (2), MEG (1)
- 510(k) review time since 2016: median 236 days, against 146 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shina Corp.: 2 (https://510kreport.com/company/shina)
- Poonglim Pharmatech, Inc.: 2 (https://510kreport.com/company/poonglim-pharmatech)

## Its most-cited devices
- K152879: Sure-Fine Insulin Syringes (2016), cited by 1
- K191531: Sure-Fine Insulin Syringes (2019), cited by 1
- K210848: Sure-Fine Insulin Syringes (2022), cited by 1
- K152877: SureFine Pen Needle (2016), cited by 1

## Recent decisions
- K250510: Sure-Fine Insulin Syringes (Oct 15, 2025)
- K250658: SureFine Pen Needle (Apr 3, 2025)
- K231165: Shina Syringe; Shina Safety Syringe (Oct 27, 2023)
- K210848: Sure-Fine Insulin Syringes (Mar 1, 2022)
- K191531: Sure-Fine Insulin Syringes (Sep 6, 2019)
- K152879: Sure-Fine Insulin Syringes (Sep 9, 2016)
- K152877: SureFine Pen Needle (Jun 7, 2016)

Source page: https://510kreport.com/company/shina-med