# K210621: Oral/Enteral Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
- Decided: Apr 28, 2021 after 57 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: 3 generations back to K951871 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122373: Neomed Oral/Enteral Syringe, Neomed, Inc. (2012) Summary page 6.

## Cited in the summary but kept off the family tree
- K192179: Oral/Enteral Syringe. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Indications for use
The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

Source page: https://510kreport.com/device/K210621
Methodology: https://510kreport.com/methodology