510(k) clearance

Profoject™ Safety Sliding Blood Collection Set

FDA 510(k) source

510(k) number

K262215

Applicant

CMT Health PTE., Ltd.

Decision date

Sep 25, 2026

Date received

Jun 30, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

JKA

Device type

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device class

Class II

Regulation

21 CFR 862.1675

Advisory committee

Clinical Chemistry

Statement or summary

Summary

Third party

N

Location

Singapore, SG