# K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Med Co., Ltd.
- Decided: May 25, 2022 after 439 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 K951254 (1995). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113186: Sterile Insulin Pen Needle, Shina Corp. (2012) Summary page 4.
- K172095: Autokeeper, Medexel Co.,Ltd (2018) Summary page 4.

## Most influential descendants
- K260855: Profoject™ Safety Pen Needles (2026), 0 descendants of its own

## Indications for use
This device is intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K210748
Methodology: https://510kreport.com/methodology