# K100005: BD Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Co.
- Decided: Apr 15, 2010 after 101 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: 1 generation back to K051899 (2005). 1 ancestor in all.
59 later devices descend from it; 10 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005)
- (no number) BD Pen Needle 31G x 5mm: named in the summary without a submission number
- (no number) BD Pen Needle 31G x 8mm: named in the summary without a submission number

## Most influential descendants
- K112332: Fine Ject Insulin Pen Needle (2012), 21 descendants of its own
- K123300: BD Pen Needle (2013), 20 descendants of its own
- K120690: Insulin Pen Needle (2012), 20 descendants of its own
- K133059: Insulin Pen Needle (2014), 18 descendants of its own
- K131358: BD Pen Needle (2013), 11 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/K100005
Methodology: https://510kreport.com/methodology