# K112789: Easy Touch

- Pathway: 510(k) (Traditional)
- Applicant: Mhc Medical Products, LLC
- Decided: Dec 23, 2011 after 88 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: 3 generations back to K973899 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080904: Feel-Fine Insulin Pen Needle, Feel Tech (2008) Summary page 1.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 1.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 1.

## Recalls of this device
- Apr 6, 2018 · Class II · Z-1780-2018: The retail shelf cartons may be labeled with an incorrect lot number.
- Apr 6, 2018 · Class II · Z-1779-2018: The retail shelf cartons may be labeled with an incorrect lot number.

## Indications for use
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes

Source page: https://510kreport.com/device/K112789
Methodology: https://510kreport.com/methodology