# K161170: BD Eclipse Hypodermic Needle

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: May 27, 2016 after 31 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 4.

## Most influential descendants
- 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 (2016), 1 descendant of its own
- K222852: Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (2023), 0 descendants of its own
- K213054: Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe (2022), 0 descendants of its own

## Recalls of this device
- Dec 20, 2016 · Class II · Z-1440-2017: BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.

## Indications for use
The BD Eclipse™ 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 Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes. 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.

Source page: https://510kreport.com/device/K161170
Methodology: https://510kreport.com/methodology