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510(k) K253268

Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap by CMT Health PTE., Ltd. — Product Code PNR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 8, 2026
Date Received: September 29, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enteral Syringes With Enteral Specific Connectors
Device Class: Class II
Regulation Number: 876.5980
Review Panel: GU
Submission Type

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

Other clearances by CMT Health PTE., Ltd.

K253068 — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe (February 23, 2026)
K252814 — Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low (February 19, 2026)
K252631 — Profoject Disposable Needle (October 16, 2025)
K252033 — Profoject Disposable Syringe, Profoject Disposable Syringe with Needle (July 25, 2025)
K251585 — Profoject Enteral Feeding Syringe (July 18, 2025)

Other clearances for product code PNR

K251585 — Profoject Enteral Feeding Syringe (July 18, 2025)
K243652 — Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syring (December 19, 2024)
K231300 — Nutricair Enteral Syringe with ENFit (October 6, 2023)
K222772 — Oral/Enteral Syringe with ENFit connector (August 17, 2023)
K222155 — O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral (September 16, 2022)
K211661 — ENFit enteral syringes (NUTRIFIT) (February 28, 2022)
K211593 — Enteral Pump Syringe (September 30, 2021)
K203613 — ENFit Reusable Enteral Syringe (August 27, 2021)
K211025 — Oral/Enteral Syringe with ENFit connector (June 30, 2021)
K203410 — ENFit Disposable Enteral Syringe (June 28, 2021)