# K161141: ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

- Pathway: 510(k) (Traditional)
- Applicant: Pentaferte Italia S.R.L.
- Decided: Mar 22, 2017 after 334 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: 4 generations back to K951871 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143344: NeoMed NeoConnect Enteral Syringes with ENFit Connector, Neomed, Inc. (2015) Summary page 5.
- K122373: Neomed Oral/Enteral Syringe, Neomed, Inc. (2012) Summary page 5.

## Most influential descendants
- K211661: ENFit enteral syringes (NUTRIFIT) (2022), 0 descendants of its own
- K211593: Enteral Pump Syringe (2021), 0 descendants of its own

## Indications for use
ENFit enteral pump syringes PENTA ENFit TM and ENFit enteral pump syringes NUTRIFIT TM deliver nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump. ENFit enteral pump syringes (PENTA ENFit TM and NUTRIFIT TM) are intended for neonatal, pediatric and adult use. ENFit enteral pump syringes are single use devices.

Source page: https://510kreport.com/device/K161141
Methodology: https://510kreport.com/methodology