# K153706: Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: SteriLance Medical (Suzhou), Inc.
- Decided: Aug 29, 2016 after 250 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: 6 generations back to K973899 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133059: Insulin Pen Needle, Wenzhou Beipu Science & Technology Co., Ltd. (2014) Summary page 4.

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

Source page: https://510kreport.com/device/K153706
Methodology: https://510kreport.com/methodology