# K123300: BD Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 18, 2013 after 87 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.
20 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 1.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 1.

## Most influential descendants
- K131358: BD Pen Needle (2013), 11 descendants of its own
- K162516: BD Pen Needle (2016), 10 descendants of its own
- K140516: Terumo Pen Injector Needle 34 (2014), 4 descendants of its own
- K171982: Droplet Pen Needle (2018), 3 descendants of its own
- K192082: Droplet Pen Needle 34G (2020), 2 descendants of its own

## Indications for use
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Source page: https://510kreport.com/device/K123300
Methodology: https://510kreport.com/methodology