DISETRONIC PENFINE INJECTION PEN NEEDLE— 510(k) K982399

Clearance details

Applicant

Disetronic Medical Systems

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1998-07-10

Decision date

1998-08-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Myers, FL, US

• 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

• K013782 — DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE2001-11-20
• K994186 — DISETRONIC D-TRON INSULIN INFUSION PUMP1999-12-30
• K994197 — DISENTRONIC PENFINE INJECTION PEN NEEDLE1999-12-29
• K993666 — DISETRONIC PEN P1001999-11-22
• K991376 — DAHEDI INSULIN INFUSION PUMP1999-06-15

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 →