510(k) K261829
K261829 is an FDA 510(k) premarket notification submitted by CMT Health PTE., Ltd. for the device "Profoject Dual-Safety Pen Needles". The FDA issued a decision of Substantially Equivalent on Jul 29, 2026. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. CMT Health PTE., Ltd. has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2026
- Date Received
- Jun 2, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)