# K141749: Carefine Pen Needle Family Including Quintapoint and Superpoint

- Pathway: 510(k) (Special)
- Applicant: Facet Technologies, LLC
- Decided: Jul 29, 2014 after 29 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.
No later device cites it as a predicate yet.
0 of 17 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.

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

Source page: https://510kreport.com/device/K141749
Methodology: https://510kreport.com/methodology