FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
K Number: K253268
·
Decision Apr 8, 2026
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
32
Applicant Total
8
Review Days
191
Basic Information
- 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
- K Number
- K253268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CMT Health PTE., Ltd.
- Date Received
- September 29, 2025
- Decision Date
- April 8, 2026
- Product Code
- PNR
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNR), ordered by most recent decision date.
Profoject™ Enteral Feeding Syringe
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Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)
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FDA 510(k)
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Other Clearances by CMT Health PTE., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | Jun 12, 2026 | Substantially Equivalent |
| K260855 | Profoject™ Safety Pen Needles | Jun 10, 2026 | Substantially Equivalent |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | Feb 23, 2026 | Substantially Equivalent |
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | Feb 19, 2026 | Substantially Equivalent |
| K252631 | Profoject™ Disposable Needle | Oct 16, 2025 | Substantially Equivalent |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | Jul 25, 2025 | Substantially Equivalent |
| K251585 | Profoject™ Enteral Feeding Syringe | Jul 18, 2025 | Substantially Equivalent |