# K220614: MEDOJECT fine Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: Chirana T. Injecta
- Decided: Jun 15, 2022 after 104 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 K051899 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213407: UltiCare Disposable Pen Needles, Ultimed Incorporated (2021) Summary page 4.

## Indications for use
MEDOJECT™ fine Pen Needles for single use are intended for subcutaneous delivery of insulin in conjunction with injection pens.

Source page: https://510kreport.com/device/K220614
Methodology: https://510kreport.com/methodology