# K252631: Profoject™ Disposable Needle

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Oct 16, 2025 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: 8 generations back to K904198 (1990). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211214: Sterile Hypodermic Needles for Single Use, Azur Medical Company, Inc. (2021) Summary page 5.

## Indications for use
The Profoject™ Disposable Needle is intended to be used with a Luer lock or Luer slip syringe and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K252631
Methodology: https://510kreport.com/methodology