FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
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
K Number: K252814
·
Decision Feb 19, 2026
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
11
Applicant Total
8
Review Days
168
Basic Information
- Device Name
- 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
- K Number
- K252814
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CMT Health PTE., Ltd.
- Date Received
- September 4, 2025
- Decision Date
- February 19, 2026
- Product Code
- QNQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QNQ | Low Dead Space Piston Syringe | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QNQ), ordered by most recent decision date.
TSK Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Small Volume 0.2mL Syringe
FDA 510(k)
FDA Class 2
·General Hospital
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
FDA 510(k)
FDA Class 2
·General Hospital
Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
FDA 510(k)
FDA Class 2
·General Hospital
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
FDA 510(k)
FDA Class 2
·General Hospital
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by CMT Health PTE., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | Jun 12, 2026 | Substantially Equivalent |
| K260855 | Profoject Safety Pen Needles | Jun 10, 2026 | Substantially Equivalent |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | Apr 8, 2026 | Substantially Equivalent |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | Feb 23, 2026 | Substantially Equivalent |
| K252631 | Profoject Disposable Needle | Oct 16, 2025 | Substantially Equivalent |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | Jul 25, 2025 | Substantially Equivalent |
| K251585 | Profoject Enteral Feeding Syringe | Jul 18, 2025 | Substantially Equivalent |