# K100209: BD Eclipse Needle with Smartslip Technology

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 19, 2010 after 25 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K010188 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010188: BD Eclipse Hypodermic Needle, Bd Medical Systems (2001)
- K043397: Modification to BD Eclipse Hypodermic Needle, Becton, Dickinson & CO (2004) Summary page 2.

## Most influential descendants
- K214004: CCBIO ASCPO Needle (2022), 0 descendants of its own

## Indications for use
The BD Eclipser11i Needle with SrnartSlipTm Technology is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The J3D Eclipse""" Needle with SiiartSlipTM Technology is compatible for use with standard luer-slip and luer-lock syringes. TEhe BD Eclipsen"I Needle with SniartSl~ipTnI Technology contains a mechanism that covers the needle point afiter use. In the activated position the needle cover" guards against accidental needle sticks durinp- normal handling and disposal of the used -needle/syringe combination.

Source page: https://510kreport.com/device/K100209
Methodology: https://510kreport.com/methodology