# K243207: BD Vacutainer® Eclipse™ Blood Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 3, 2025 after 275 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220212: BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder, Becton, Dickinson and Company (2023) Summary page 5.

## Indications for use
The BD Vacutainer® Eclipse™ Blood Collection Needle is a sterile, single-use, medical device specifically intended to be used by healthcare professionals experienced with venipuncture on adults and children in accordance with the instructions for use for the collection of multiple venous blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needlesticks.

Source page: https://510kreport.com/device/K243207
Methodology: https://510kreport.com/methodology