Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k) K253068 · CMT Health PTE., Ltd.
510(k) numberK253068
Submission
- Device name
- Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
- Applicant
- CMT Health PTE., Ltd.
Singapore, SG - Received
- September 22, 2025
- Decision date
- February 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
| K252518 | DuoprossTM Smart Cap (Type I)FMF · Traditional | Duopross Meditech Corporate | 12/17/2025SE |
More from Duopross Meditech Corporate
| 510(k) | Device | Decision |
|---|---|---|
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | 07/15/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | 06/12/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | 06/10/2026SE |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…PNR · Traditional | 04/08/2026SE |
| K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead…QNQ · Traditional | 02/19/2026SE |
| K252631 | Profoject Disposable NeedleFMI · Traditional | 10/16/2025SE |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with NeedleFMF · Traditional | 07/25/2025SE |
| K251585 | Profoject Enteral Feeding SyringePNR · Traditional | 07/18/2025SE |
Questions and answers
When was Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe cleared by the FDA?
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe (K253068) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 154 days after the submission was received.
What is the product code of K253068?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.