# K260855: Profoject™ Safety Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Jun 10, 2026 after 86 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles, W. L. Med Co., Ltd. (2022) Summary page 5.

## Indications for use
Profoject™ Safety Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs. The device is intended for use in patients weighing ≥ 3.5 kg, from neonates to adults.

Source page: https://510kreport.com/device/K260855
Methodology: https://510kreport.com/methodology