Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)— 510(k) K260933

Clearance details

Applicant

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2026-03-20

Decision date

2026-08-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou, CN

• K261829 — Profoject™ Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject™ Pen Needles (Model A; Model B)2026-07-15
• K260855 — Profoject™ Safety Pen Needles2026-06-10
• K254273 — Verisafe Safety Sterile Needles (SSN)2026-04-16
• K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle2026-03-25

• K260301 — Vial Adapter2026-06-05
• K233287 — Vent Vial Adapter2024-07-26
• K233277 — Filter Needle for Single Use2024-05-10
• K233284 — Vial Adapter with Filter2024-05-01
• K222718 — Vial Adapter2023-03-10

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

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 →