Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brosmed Medical Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
369 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet | Brosmed Medical Co., Ltd. | 2025-02-27 | 90 | 0 |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024-10-22 | 151 | 0 |
| K230705 | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2023-04-11 | 28 | 0 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2022-07-19 | 369 | 0 |
| K203390 | Artimes pro Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2021-04-14 | 147 | 0 |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Cathet | Brosmed Medical Co., Ltd. | 2016-12-13 | 253 | 0 |
| K153742 | Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016-08-08 | 224 | 0 |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016-07-29 | 179 | 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