Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canyon Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
242 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. | 2025-09-23 | 242 | 0 |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | 2024-09-26 | 94 | 0 |
| K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | 2024-09-20 | 88 | 0 |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Bio | Canyon Medical, Inc. | 2024-01-17 | 114 | 0 |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Bio | Canyon Medical, Inc. | 2023-04-03 | 193 | 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