# K131358: BD Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 16, 2013 after 67 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: 3 generations back to K051899 (2005). 3 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123300: BD Pen Needle, Becton, Dickinson & CO (2013) Summary page 1.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 1.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 2.

## Most influential descendants
- K162516: BD Pen Needle (2016), 10 descendants of its own
- K171982: Droplet Pen Needle (2018), 3 descendants of its own
- K182320: BD Contoured Base Pen Needle (2018), 2 descendants of its own
- K213407: UltiCare Disposable Pen Needles (2021), 1 descendant of its own
- K260739: Profoject™ Pen Needles (Model A; Model B) (2026), 0 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/K131358
Methodology: https://510kreport.com/methodology