510(k) Report

FDA applicant

Ningbo Tianyi Medical Appliance Co., Ltd.

Ningbo, CN3 decisions2021–20250 recalls

FDA records 3 decisions for Ningbo Tianyi Medical Appliance Co., Ltd. (Ningbo, CN) from 2021 to 2025: 3 510(k) clearances. Most are in product codes PNR (Enteral Syringes With Enteral Specific…) and FJK (Set, Tubing, Blood, With And Without…). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Ningbo Tianyi Medical Appliance Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 22025: 1
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ningbo Tianyi Medical Appliance Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PNREnteral Syringes With Enteral Specific Connectors2decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211025Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd. · 20212cite it

What has FDA decided for it lately?

  • K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd. · 2025
  • K211025Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd. · 2021
  • K210621Oral/Enteral SyringeNingbo Tianyi Medical Appliance Co., Ltd. · 2021

All 3 as Ningbo Tianyi Medical Appliance Co., Ltd. →