# K163578: EasyTouch Safety Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Mhc Medical Products, LLC
- Decided: Aug 3, 2018 after 591 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.
4 later devices descend from it; 1 cites it directly.
0 of 7 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 4.

## Most influential descendants
- K220129: Promisemed X-Safety Pen Needle (2022), 3 descendants of its own
- K252886: Pen Needle (2026), 1 descendant of its own
- K261719: Promisemed X-Safety Pen Needle (2026), 0 descendants of its own
- K262427: Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) (2026), 0 descendants of its own

## Indications for use
The EasyTouch™ Safety Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. 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/K163578
Methodology: https://510kreport.com/methodology