SAFETYGLIDE NEEDLE— 510(k) K951254

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1995-03-21

Decision date

1995-10-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lake, NJ, 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

• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
• K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
• K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
• K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
• K001364 — BD DIRECTIGEN FLU A+B2000-06-28

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-2889-2020 — BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in packClass II·Terminated·Becton Dickinson & Company·20200728
• Z-0315-2018 — SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.Class II·Terminated·Centurion Medical Products Corporation·20170705
• Z-3116-2017 — BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackagingClass II·Terminated·Becton Dickinson & Company·20170613
• Z-2748-2017 — BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combinationClass II·Terminated·Becton Dickinson & Company·20160916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951254.