# K021475: BD Single Lumen Needle, Syringe and Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Bd
- Decided: Jul 19, 2002 after 72 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931367 (1993). 8 ancestors in all.
100 later devices descend from it; 7 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 1.
- K002938: B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000) Summary page 1.
- K970737: B-D Ultra-Fine II Short 31G X 5/16 Pen Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 1.
- K950466: B-D Ultra-Fine II Pen Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.
- K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer, Becton Dickinson Infusion Therapy Systems, Inc. (2002)
- K931367: Vacutainer Brand Luer Adapter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 1.
- K965202: Vacutainer Brand Safety-Lok Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 1.
- K972404: Vacutainer Brand Safety Blood Collection Assembly (Multiple), Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 1.
- (no number) BD Hypodermic Needles: named in the summary without a submission number

## Most influential descendants
- K070440: BD Hypoint Needle (2007), 91 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (2019), 13 descendants of its own

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0588-2021: BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use
- May 31, 2017 · Class II · Z-0207-2018: Hub damage resulting in breakage and/or leakage during use.
- Oct 8, 2011 · Not classified · Z-1009-2012: Becton Dickinson has identified clogged needles.

## Indications for use
The needles are intended for general purpose fluid injection/aspiration,infusion, venipuncture to obtain blood collection and insulin injection.

Source page: https://510kreport.com/device/K021475
Methodology: https://510kreport.com/methodology