510(k) K253068
K253068 is an FDA 510(k) premarket notification submitted by CMT Health PTE., Ltd. for the device "Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe". The FDA issued a decision of Substantially Equivalent on February 23, 2026. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. CMT Health PTE., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2026
- Date Received
- September 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type