# K060007: BD Autoshield Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 23, 2006 after 79 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: 1 generation back to K051899 (2005). 1 ancestor in all.
18 later devices descend from it; 4 cite it directly.
0 of 20 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). Our reading of the summary gave K051889, FDA’s number for Carevent CA and Dra (O-Two Medical Technologies, Inc.). Corrected to the number one digit away that FDA lists under the company the summary names beside it.

## Most influential descendants
- K131123: Clickfine Autoprotect Pen Needle (2013), 8 descendants of its own
- K152514: Clickfine AutoProtect Pen Needle (2015), 7 descendants of its own
- K181447: Safety insulin needle for single use (2019), 4 descendants of its own
- K163578: EasyTouch Safety Pen Needle (2018), 4 descendants of its own
- K220129: Promisemed X-Safety Pen Needle (2022), 3 descendants of its own

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-0838-2007: Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)

## Indications for use
The BD AutoShieldTM Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exinatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Source page: https://510kreport.com/device/K060007
Methodology: https://510kreport.com/methodology