# K010188: BD Eclipse Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bd Medical Systems
- Decided: Mar 1, 2001 after 38 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
No predicates in its family tree.
14 later devices descend from it; 7 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043397: Modification to BD Eclipse Hypodermic Needle (2004), 4 descendants of its own
- K161170: BD Eclipse Hypodermic Needle (2016), 3 descendants of its own
- K123684: Sol-Care Safety Needle (2013), 2 descendants of its own
- 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
- K100209: BD Eclipse Needle with Smartslip Technology (2010), 1 descendant of its own

Source page: https://510kreport.com/device/K010188
Methodology: https://510kreport.com/methodology