# K003461: BD Vacutainer Passive Shielding Blood Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Feb 1, 2001 after 86 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K072602: Vacuette Premium Safety Needle System (2008), 2 descendants of its own
- K111424: Vacuette Premium Safety Needle System Tube-Touch (2011), 1 descendant of its own
- K120281: Dignity Power Injectable Titanium Port (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K003461
Methodology: https://510kreport.com/methodology