# K253268: Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Apr 8, 2026 after 191 days
- Product code: PNR (Enteral Syringes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801558 (1980). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183540: Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL), Neomed, Inc. (2019) Summary page 7.
- K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port, Cedic S.R.L. (2014) Summary page 7.
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps, Neomed, Inc. (2015) Summary page 7.

## Indications for use
Profoject™ Enteral/ Oral Feeding Syringe: The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or non-clinical settings by users ranging from clinicians to laypersons in all age groups. Profoject™ Reusable Enteral/ Oral Feeding Syringe: The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only. Profoject™ ENFit Adaptor: The Profoject™ ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. Profoject™ Enteral Feeding Syringes Cap: The Profoject™ Enteral Feeding Syringes Cap is used to prevent fluid loss and contamination of syringe contents until ready for use.

Source page: https://510kreport.com/device/K253268
Methodology: https://510kreport.com/methodology