K253068

Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe

510(k) number: K253068
Device name: Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
Applicant: CMT Health PTE., Ltd. SG
Product code: FMF — Syringe, Piston
Decision date: 2026-02-23
Date received: 2025-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Flag: Third-party review
Advisory committee: General Hospital

Also available from FDA: K253068.pdf

Official FDA record: K253068

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.