Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe— 510(k) K253068
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K253068 for Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe, Substantially Equivalent on 2026-02-23. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Summary
CMT Health lists two names, Profoject Insulin Syringes and Profoject Safelock Disposable Insulin Syringe, under product code FMF, piston syringe. The record doesn't say how the two differ.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k). The record flags it as a third-party review.
CMT Health filed from Singapore. The decision came 154 calendar days after FDA received it (September 22, 2025 to February 23, 2026), and it was substantially equivalent.
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.