# K032528: BD Eclipse Bifurcated Needle

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Sep 9, 2003 after 25 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BD Eclipse™ Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering cpidermal allergens. The BD Eclipse™ Bifurcated 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.

Source page: https://510kreport.com/device/K032528
Methodology: https://510kreport.com/methodology