# K110703: BD Autoshield Duo Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 27, 2011 after 135 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: 2 generations back to K051899 (2005). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060007: BD Autoshield Pen Needle, Becton, Dickinson & CO (2006) Summary page 1.

## Most influential descendants
- K223286: BD AutoShield Duo™ Pen Needle (2022), 1 descendant of its own
- K261266: MOWANA™ Auto Duo (2026), 0 descendants of its own

## Indications for use
The BD AutoShield TM" Duo Pen Needle is intended for use with pen injector devices for the injection of drugs. The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

Source page: https://510kreport.com/device/K110703
Methodology: https://510kreport.com/methodology