# K261829: Profoject™ Dual-Safety Pen Needles

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Jul 29, 2026 after 57 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: 3 generations back to K951254 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151311: Safe Block Pen Needle, Artsana S.P.A (2016) Summary page 5.

## Indications for use
Profoject™ Dual-Safety Pen Needles are intended for use with pen injector devices for the injection of drugs. The device is intended for use in patients weighing ≥ 3.5 kg, from neonates to adults. Additionally, the attached safety shields automatically lock in place after use and are intended to reduce the occurrence of accidental needle-stick injuries from both the patient end and the pen-connection end of the needle.

Source page: https://510kreport.com/device/K261829
Methodology: https://510kreport.com/methodology