K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall— 510(k) K192057

Clearance details

Applicant

Terumo Europe N.V.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2019-08-01

Decision date

2019-10-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Leuven, BE

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• K261829 — Profoject Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

• K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)2025-07-08
• K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)2025-05-29
• K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)2025-04-04
• K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M)2023-10-18
• K212095 — SurGuard3 Safety Hypodermic Needle2022-08-22

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 →