Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle— 510(k) K260514
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K260514 for Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle, Substantially Equivalent on 2026-06-12. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Summary
CMT Health's clearance covers three Profoject products: the Safety Needle, the Syringe with Safety Needle, and the Low Dead Space Syringe with Safety Needle. They're filed under FMF, piston syringes, and the record gives no sizes or gauges.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel. The submission was a Traditional 510(k).
CMT Health filed from Singapore. The decision came 115 calendar days after FDA received it (February 17 to June 12, 2026).
Clearance details
- Applicant
- CMT Health PTE., Ltd.
- Product code
- Product code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code FMF
view allMore clearances from CMT Health PTE., Ltd.
view allAdverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.