BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET— 510(k) K021475
Substantially EquivalentBd
FDA 510(k) clearance K021475 for BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET, Substantially Equivalent on 2002-07-19. Applicant: Bd. Device class: 2.
Clearance details
- Applicant
- Bd
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code FMI
view all- K261719 — Promisemed X-Safety Pen Needle
- 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)
- 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)
- K261829 — Profoject Dual-Safety Pen Needles
- K260739 — Profoject Pen Needles (Model A; Model B)
More clearances from Bd
view all- K253445 — BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
- K221504 — BD Surgiphor Antimicrobial Irrigation System
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K021475
K-number listed on FDA's recall record- Z-0588-2021 — BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
- Z-0207-2018 — BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021475.
Data sourced from openFDA. This site is unofficial and independent of the FDA.