# K160575: CareSens Pen Needle, Softip Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Yidobio, Inc.
- Decided: Sep 7, 2016 after 190 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: 3 generations back to K973899 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063466: Top Fine, Daejin Tech Medical Manufacturing Co., Ltd. (2007) Summary page 5.

## Indications for use
The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

Source page: https://510kreport.com/device/K160575
Methodology: https://510kreport.com/methodology