# K140568: Carefine Pen Needle with Quintapoint and Superpoint

- Pathway: 510(k) (Special)
- Applicant: Facet Technologies, LLC
- Decided: May 13, 2014 after 69 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). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133100: Carefine Pen Needle, Facet Technologies (2014) Summary page 1.

## Most influential descendants
- K171144: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel (2017), 0 descendants of its own

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

Source page: https://510kreport.com/device/K140568
Methodology: https://510kreport.com/methodology