# K260514: Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Jun 12, 2026 after 115 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K771205 (1977). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212920: Sterile Safety Syringe with Needle for Single Use,  Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use, Shandong Weigao Group Medical Polymer Co., Ltd. (2022) Summary page 6.
- K232943: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe, Smiths Medical Asd, Inc. (2024) Summary page 6.

## Indications for use
The Profoject™ Safety Needle is intended to be used with a Luer slip or Luer lock syringe for withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Profoject™ Syringe with Safety Needle is intended for use in the withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Profoject™ Low Dead Space Syringe with Safety Needle is intended for use in the withdrawal and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Source page: https://510kreport.com/device/K260514
Methodology: https://510kreport.com/methodology