# K170824: BD Vacutainer Eclipse Signal Blood Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 20, 2018 after 518 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 K972404 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608, Becton Dickinson Vacutainer Systems (1998) Summary page 4.

## Indications for use
The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is a sterile, single use, medical device specifically intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The device incorporates a flash technology to indicate venous access and a hinged safety shield. In the activated position, the safety shield protects against an accidental needle stick injury during normal handling and disposal.

Source page: https://510kreport.com/device/K170824
Methodology: https://510kreport.com/methodology