VAKU-8 BLOOD COLLECTION NEEDLES— 510(k) K090426

Clearance details

Applicant

Myco Medical Supplies, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2009-02-19

Decision date

2009-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cary, NC, 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

• K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles2021-09-29
• K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder2018-05-14
• K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER2006-01-19
• K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET2001-04-12
• K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES2000-06-02

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 →