# K161553: BD SafeAssist

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 6, 2016 after 30 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 K051899 (2005). 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)
- K060007: BD Autoshield Pen Needle, Becton, Dickinson & CO (2006) Summary page 4.

## Indications for use
The BD SafeAssist™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Source page: https://510kreport.com/device/K161553
Methodology: https://510kreport.com/methodology