Profoject Disposable Syringe, Profoject Disposable Syringe with Needle— 510(k) K252033
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K252033 for Profoject Disposable Syringe, Profoject Disposable Syringe with Needle, Substantially Equivalent on 2025-07-25. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Clearance details
- Applicant
- CMT Health PTE., Ltd.
- Product code
- 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 all- K261829 — Profoject Dual-Safety Pen Needles
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
- K260855 — Profoject Safety Pen Needles
- K253268 — Profoject Enteral/Oral Feeding Syringe +3 more
Adverse 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.