# K121283: BD Emerald Saf-T Single Use, Hypodermic

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: May 30, 2012 after 30 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980987 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113241: BD Emerald Single Use, Hypodermic Syringe, Becton Dickinson (2011) Summary page 2.
- K010188: BD Eclipse Hypodermic Needle, Bd Medical Systems (2001)
- K043397: Modification to BD Eclipse Hypodermic Needle, Becton, Dickinson & CO (2004) Summary page 1.

## Indications for use
The BD EmeraldTM Saf-T Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.

Source page: https://510kreport.com/device/K121283
Methodology: https://510kreport.com/methodology