# K162516: BD Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 9, 2016 after 91 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K051899 (2005). 4 ancestors in all.
10 later devices descend from it; 4 cite 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)
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 4.
- K131358: BD Pen Needle, Becton, Dickinson & CO (2013) Summary page 4.

## Most influential descendants
- 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
- K230635: Pen Needle (2023), 0 descendants of its own

## Recalls of this device
- Mar 16, 2021 · Class II · Z-1933-2021: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Oct 23, 2020 · Class II · Z-0508-2021: Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to u

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

Source page: https://510kreport.com/device/K162516
Methodology: https://510kreport.com/methodology