Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dongguan TT Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
222 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | 2026-03-20 | 37 | 0 |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2024-07-31 | 113 | 0 |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2023-10-12 | 113 | 0 |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coron | Dongguan TT Medical, Inc. | 2023-06-29 | 136 | 0 |
| K222663 | MultiStage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-09 | 188 | 0 |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-01 | 222 | 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