# K182320: BD Contoured Base Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 20, 2018 after 115 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: 5 generations back to K051899 (2005). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162516: BD Pen Needle, Becton, Dickinson and Company (2016) Summary page 5.

## Most influential descendants
- K213156: BD Nano 2nd Gen Pen Needle (2021), 0 descendants of its own
- K212015: BD Nano 2nd Gen Pen Needle (2021), 0 descendants of its own

## Indications for use
Becton Dickinson Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K182320
Methodology: https://510kreport.com/methodology