Dual-Safety Pen Needle— 510(k) K191853

Clearance details

Applicant

Promisemed Hangzhou Meditech Co., Ltd.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2019-07-10

Decision date

2019-09-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou City, CN

• K261719 — Promisemed X-Safety Pen Needle2026-08-25
• K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)2026-08-10
• K260933 — 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)2026-08-07
• K261829 — Profoject Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

• K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12
• K261045 — Verifine Safety Lancets2026-05-01
• K254273 — Verisafe Safety Sterile Needles (SSN)2026-04-16
• K250192 — Verisafe Safety Retractable Insulin Syringes2025-12-10
• K250961 — Blood collection tube holders2025-06-04

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 →