# K043397: Modification to BD Eclipse Hypodermic Needle

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 29, 2004 after 19 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: 1 generation back to K010188 (2001). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 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) Summary page 1.

## Most influential descendants
- K100209: BD Eclipse Needle with Smartslip Technology (2010), 1 descendant of its own
- K214004: CCBIO ASCPO Needle (2022), 0 descendants of its own
- K121283: BD Emerald Saf-T Single Use, Hypodermic (2012), 0 descendants of its own
- K082908: Novaguard, Model 3611001 (2009), 0 descendants of its own

## Indications for use
The BD EclipseTM Hypodermic Needle 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 BD EclipseTM Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes. The BD EclipseTM Hypodermic Needle contains a mechanism that covers the needle point 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.

Source page: https://510kreport.com/device/K043397
Methodology: https://510kreport.com/methodology