# K260739: Profoject™ Pen Needles (Model A; Model B)

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Jul 15, 2026 after 131 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171982: Droplet Pen Needle, Htl-Strefa S.A (2018) Summary page 7.

## Indications for use
Profoject™ Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K260739
Methodology: https://510kreport.com/methodology