510(k) K262242
K262242 is an FDA 510(k) premarket notification submitted by CMT Health PTE., Ltd. for the device "Profoject Safe Push Button Blood Collection Sets". The FDA issued a decision of Substantially Equivalent on Oct 28, 2026. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. CMT Health PTE., Ltd. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 2026
- Date Received
- Jul 1, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type
- 510(k)