Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ningbo Tianyi Medical Appliance Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 | 146 | 0 |
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 | 85 | 0 |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda