# K120690: Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Tiger Medical Products, Ltd.
- Decided: Jun 22, 2012 after 107 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: 4 generations back to K973899 (1997). 6 ancestors in all.
20 later devices descend from it; 2 cite 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)
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 1.
- K112332: Fine Ject Insulin Pen Needle, Twobiens Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- 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
- K202319: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (2021), 1 descendant of its own

## Indications for use
Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K120690
Methodology: https://510kreport.com/methodology