# K112332: Fine Ject Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Twobiens Co., Ltd.
- Decided: Jan 10, 2012 after 151 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: 3 generations back to K973899 (1997). 5 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 27 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 2.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010)

## Most influential descendants
- K120690: Insulin Pen Needle (2012), 20 descendants of its own
- K133059: Insulin Pen Needle (2014), 18 descendants of its own
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (2017), 9 descendants of its own
- K181069: Disposable Insulin Pen Needle (2018), 3 descendants of its own
- K152824: Medt Pen Needle (2016), 2 descendants of its own

## 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/K112332
Methodology: https://510kreport.com/methodology