# K231300: Nutricair Enteral Syringe with ENFit

- Pathway: 510(k) (Traditional)
- Applicant: Cair Lgl
- Decided: Oct 6, 2023 after 155 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: 10 generations back to K801558 (1980). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193657: Disposable Enteral Feeding Syringe with Enfit Connector, Shinva Ande Healthcare Apparatus Co., Ltd. (2020) Summary page 5.

## Indications for use
NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric and adult patient populations. These devices are intended to be used in clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).

Source page: https://510kreport.com/device/K231300
Methodology: https://510kreport.com/methodology