TERUMO(R) NEEDLE— 510(k) K121607

Clearance details

Applicant

Terumo (Philippines) Corporation

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2012-06-01

Decision date

2012-11-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Elkton, MD, 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

• K152362 — Terumo SurGuard 3 Safety Hypodermic Needle2015-10-16
• K133280 — TERUMO SURFLO I.V. CATHETER2014-06-12
• K122249 — TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE2012-08-28
• K113422 — TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE2012-03-05

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 →

• Z-1998-2019 — Terumo Sur-vet Needle, 20G x 1", Product Code 100204Class II·Terminated·Terumo Medical Corporation·20190208
• Z-1999-2019 — Terumo Sur-vet Needle, 22G x 1", Product Code 100211Class II·Terminated·Terumo Medical Corporation·20190208
• Z-2000-2019 — Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215Class II·Terminated·Terumo Medical Corporation·20190208
• Z-2001-2019 — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220Class II·Terminated·Terumo Medical Corporation·20190208
• Z-2002-2019 — Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279Class II·Terminated·Terumo Medical Corporation·20190208
• Z-2003-2019 — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280Class II·Terminated·Terumo Medical Corporation·20190208
• Z-2004-2019 — Terumo Needle, 18G x 1", Product Code NN1825RClass II·Terminated·Terumo Medical Corporation·20190208
• Z-2005-2019 — Terumo Needle, 23G x 1", Product Code NN2325RClass II·Terminated·Terumo Medical Corporation·20190208
• Z-2006-2019 — Terumo Needle, 30G x 1/2", Product Code NN3013RClass II·Terminated·Terumo Medical Corporation·20190208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121607.