# K212015: BD Nano 2nd Gen Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Nov 19, 2021 after 144 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: 6 generations back to K051899 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182320: BD Contoured Base Pen Needle, Becton, Dickinson and Company (2018) Summary page 4.

## Recalls of this device
- Jun 18, 2024 · Class II · Z-2424-2024: BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
- Jul 26, 2023 · Class II · Z-3179-2026: 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 the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K212015
Methodology: https://510kreport.com/methodology