# K211661: ENFit enteral syringes (NUTRIFIT)

- Pathway: 510(k) (Traditional)
- Applicant: Pentaferte Italia S.R.L.
- Decided: Feb 28, 2022 after 272 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: 5 generations back to K951871 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161141: ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT, Pentaferte Italia S.R.L. (2017) Summary page 5.

## Indications for use
Nutrifit™ Single Use /Enteral Syringes with ENFit Connector (including low dose tip (LDT) versions): ENFit Nutrifit™ enteral syringes deliver enteral fluids to the gastrointestinal system of a patient who is physically unable to eat and swallow. The syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician), to clinicians to administer enteral fluids. ENFit Nutrifit™ enteral syringes are single use devices. ENFit Nutrifit™ enteral syringes are intended for pediatric and adult use.

Source page: https://510kreport.com/device/K211661
Methodology: https://510kreport.com/methodology