PUSH-ON NEEDLE 30GX8MM— 510(k) K120191

Clearance details

Applicant

Scandinavian Health Limited

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2012-01-23

Decision date

2012-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taoyuan City, TW

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• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

• K141384 — WHISPERJECT AUTOINJECTOR2014-09-12
• K124026 — LOBSTER AUTO-INJECTOR2013-09-13

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 →