# K213478: BD Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jun 28, 2022 after 242 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 6 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.

## Recalls of this device
- Jul 26, 2023 · Class II · Z-3180-2026: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

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

Source page: https://510kreport.com/device/K213478
Methodology: https://510kreport.com/methodology