# K133059: Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wenzhou Beipu Science & Technology Co., Ltd.
- Decided: Feb 25, 2014 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: 5 generations back to K973899 (1997). 7 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120690: Insulin Pen Needle, Tiger Medical Products, Ltd. (2012) Summary page 2.

## Most influential descendants
- 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
- K210059: Promisemed Insulin Pen Needle (2021), 1 descendant of its own

## Indications for use
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K133059
Methodology: https://510kreport.com/methodology