# K162081: BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle,  BD 1ml Luer-lok Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 19, 2016 after 145 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931367 (1993). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941562: 1ML Luer-Lok Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 6.
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set, Bd (2002) Summary page 6.
- K161170: BD Eclipse Hypodermic Needle, Becton, Dickinson and Company (2016) Summary page 6.
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 7.

## Most influential descendants
- K222852: Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (2023), 0 descendants of its own

## Indications for use
The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle 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 combination. The BD 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.

Source page: https://510kreport.com/device/K162081
Methodology: https://510kreport.com/methodology