# K211593: Enteral Pump Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Sep 30, 2021 after 129 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 6.

## Indications for use
Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. Enteral Pump Syringe is 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. Enteral Pump Syringe is intended for neonatal, pediatric and adult use. Enteral Pump Syringe is single use device.

Source page: https://510kreport.com/device/K211593
Methodology: https://510kreport.com/methodology