EASYPOINT NEEDLE— 510(k) K133635

Clearance details

Applicant

Retractable Technologies, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2013-11-26

Decision date

2014-06-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Little Elm, TX, 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

• K202325 — EasyPoint Blood Collection Plus2021-04-09
• K122355 — VANISHPOINT BLOOD COLLECTION SET2013-08-23
• K112512 — VANISHPOINT BLOOD COLLECTION SET2011-10-20
• K101708 — PATIENT SAFE LUER CAP2011-02-24
• K081420 — VANISHPOINT I.V. CATHETER2008-11-07

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-1293-2024 — EasyPoint Needle, 25G x 5/8", REF: 82091Class II·Ongoing·Retractable Technologies, Inc.·20240205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133635.