Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe +3 more— 510(k) K252814

Clearance details

Device name as filed

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

Applicant

CMT Health PTE., Ltd.

Product code

Code QNQ

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2025-09-04

Decision date

2026-02-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Singapore, SG

• K250127 — TSK Syringe2025-07-30
• K250138 — Small Volume 0.2mL Syringe2025-04-02
• 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 Needle2024-11-20
• K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe2024-05-31
• K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe2024-05-29

• K261829 — Profoject Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15
• K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle2026-06-12
• K260855 — Profoject Safety Pen Needles2026-06-10
• K253268 — Profoject Enteral/Oral Feeding Syringe +3 more2026-04-08