# K212514: Safety Pen Needle for Single Use, Insulin Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Berpu Medical Technology Co., Ltd.
- Decided: Apr 29, 2022 after 262 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: 8 generations back to K970737 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181447: Safety insulin needle for single use, Berpu Medical Technology Co., Ltd. (2019) Summary page 7.

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

Source page: https://510kreport.com/device/K212514
Methodology: https://510kreport.com/methodology