Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
by CMT Health PTE., Ltd. 510(k)
Active
510(k) K253068
Overview
The Profoject Insulin Syringes and Profoject Safelock Disposable Insulin Syringe are disposable, piston-driven insulin delivery devices designed for subcutaneous administration of insulin. These syringes feature a Safelock mechanism to prevent accidental needle sticks and ensure secure attachment of the needle, enhancing user safety and ease of use.
These syringes are intended for single-use in clinical and home settings, including general hospital environments. They are classified under FDA product code FMF and received FDA 510(k) clearance as substantially equivalent, with approval number K253068. No specific sterility or MRI safety information is provided in the data, and sizes or additional specifications are not detailed beyond the disposable, piston-type design.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253068 | Date23 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from CMT Health PTE., Ltd.
Questions
What is the primary purpose of the Profoject Insulin Syringes and how does the Safelock mechanism improve safety during use?
The Profoject Insulin Syringes are disposable, piston-driven devices designed specifically for subcutaneous insulin administration in both clinical and home settings. The Safelock mechanism enhances safety by preventing accidental needle sticks and ensuring a secure attachment of the needle, reducing the risk of exposure during use.
Are these syringes intended for reuse or single-use, and in what environments are they approved for use?
These syringes are explicitly designed for single-use only, suitable for both hospital and home settings. The FDA clearance under product code FMF (General Hospital) confirms their approval for use in clinical environments, though the same design also supports home administration.
How were these syringes classified by the FDA, and what does ‘substantially equivalent’ mean in this context?
The Profoject syringes were classified as substantially equivalent (SESE) by the FDA under a traditional 510(k) review process. This means the FDA determined they have the same intended use, technological characteristics, and performance as a legally marketed predicate device, ensuring they meet regulatory standards without requiring a full de novo classification.
What details are known about the manufacturing and regulatory submission process for these syringes?
The syringes were submitted to the FDA by CMT Health PTE., Ltd. in Singapore, with the submission received on September 22, 2025, and cleared on February 23, 2026 (K253068). The submission was reviewed by the Orthopaedics and Rehabilitation Devices Panel (HO) and involved a third-party review, indicating a thorough evaluation process.