Oral/Enteral Syringe with ENFit connector— 510(k) K211025

Name: FDA 510(k) clearance K211025
Creator: U.S. Food and Drug Administration
Published: 2021-06-30

Substantially Equivalent

Ningbo Tianyi Medical Appliance Co., Ltd.

FDA 510(k) clearance K211025 for Oral/Enteral Syringe with ENFit connector, Substantially Equivalent on 2021-06-30. Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
Product code: Code PNR
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2021-04-06
Decision date: 2021-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNR

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K252483 — Enteral Syringe (20ml, 60ml)2026-07-01
K253268 — Profoject Enteral/Oral Feeding Syringe +3 more2026-04-08
K251585 — Profoject Enteral Feeding Syringe2025-07-18
K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)2024-12-19
K231300 — Nutricair Enteral Syringe with ENFit2023-10-06

More clearances from Ningbo Tianyi Medical Appliance Co., Ltd.

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K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)2025-10-02
K210621 — Oral/Enteral Syringe2021-04-28

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.