Class Class II
Profoject™ Enteral Feeding Syringe (K251585)
Description
Profoject™ Enteral Feeding Syringe by Cmt Health Pte., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251585
Clearance Date2025-07-18
Clearance TypeTraditional
Product CodePNR
Regulation Number876.5980
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251585
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Profoject™ Enteral Feeding Syringe (K251585) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co.... | 2021 |
Trace the full predicate network for K251585
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.