Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe +3 more— 510(k) K252814
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K252814 for Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe +3 more, Substantially Equivalent on 2026-02-19. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Summary
CMT Health's record has four entries, each giving a Profoject Low Dead Space name and a Profoject Tuberculin name: a syringe, a syringe with needle, a syringe with permanent needle, and a safety syringe. They're filed under product code QNQ, low dead space piston syringe, and the record doesn't say how the entries differ beyond their names.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).
CMT Health filed from Singapore. Review took 168 calendar days (September 4, 2025 to February 19, 2026), ending in a substantially equivalent decision.
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
- Product code QNQ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code QNQ
view all- K250127 — TSK Syringe
- K250138 — Small Volume 0.2mL Syringe
- 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
- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
More clearances from CMT Health PTE., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.