# K171144: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel

- Pathway: 510(k) (Traditional)
- Applicant: Medbio, LLC
- Decided: Sep 12, 2017 after 146 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: 6 generations back to K951254 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140568: Carefine Pen Needle with Quintapoint and Superpoint, Facet Technologies, LLC (2014) Summary page 4.

## Indications for use
The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K171144
Methodology: https://510kreport.com/methodology