Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
FDA 510(k) K253268 · CMT Health PTE., Ltd.
510(k) numberK253268
Submission
- Device name
- Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
- Applicant
- CMT Health PTE., Ltd.
Singapore, SG - Received
- September 29, 2025
- Decision date
- April 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNR – Enteral Syringes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Other 510(k)s with product code PNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252483 | Enteral Syringe (20ml, 60ml)PNR · Traditional | Chirana T.Injecta,A.S. | 07/01/2026SE |
| K251585 | Profoject Enteral Feeding SyringePNR · Traditional | CMT Health PTE., Ltd. | 07/18/2025SE |
| K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with…PNR · Special | Cardinalhealth | 12/19/2024SE |
| K231300 | Nutricair Enteral Syringe with ENFitPNR · Traditional | Cair Lgl | 10/06/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/17/2023SE |
| K211661 | ENFit enteral syringes (NUTRIFIT)PNR · Traditional | Pentaferte Italia S.R.L. | 02/28/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | Jiangsu Caina Medical Co.,Ltd | 09/30/2021SE |
| K203613 | ENFit Reusable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 08/27/2021SE |
| K211025 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 06/30/2021SE |
| K203410 | ENFit Disposable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 06/28/2021SE |
More from Shantou Wealy Medical Instrument Co.,Ltd
| 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 |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | 02/23/2026SE |
| 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 Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap cleared by the FDA?
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (K253268) received a 510(k) decision of Substantially Equivalent on April 8, 2026, 191 days after the submission was received.
What is the product code of K253268?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.