Sure-Fine Insulin Syringes— 510(k) K250510

Name: FDA 510(k) clearance K250510
Creator: U.S. Food and Drug Administration
Published: 2025-10-15

Substantially Equivalent

Shina Med Corporation

FDA 510(k) clearance K250510 for Sure-Fine Insulin Syringes, Substantially Equivalent on 2025-10-15. Applicant: Shina Med Corporation. Device class: 2.

Clearance details

Applicant: Shina Med Corporation
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2025-02-21
Decision date: 2025-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Anseong-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMF

view all

K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

More clearances from Shina Med Corporation

view all

K250658 — SureFine Pen Needle2025-04-03
K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
K210848 — Sure-Fine Insulin Syringes2022-03-01
K191531 — Sure-Fine Insulin Syringes2019-09-06
K152879 — Sure-Fine Insulin Syringes2016-09-09

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.