# K252814: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle;  Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Feb 19, 2026 after 168 days
- Product code: QNQ (Low Dead Space Piston Syringe)
- 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: 10 generations back to K771205 (1977). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242291: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle, Sol-Millennium Medical, Inc. (2024) Summary page 7.
- K231856: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)), Medexel Co.,Ltd (2024) Summary page 7.

## Indications for use
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body. Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body. Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.

Source page: https://510kreport.com/device/K252814
Methodology: https://510kreport.com/methodology