Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Verathon Medical (Canada) Ulc · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
171 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cy | Verathon Medical (Canada) Ulc | 2026-05-11 | 171 | 0 |
| K230948 | BFlex™ 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2023-05-03 | 29 | 0 |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2021-11-03 | 133 | 0 |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2020-01-16 | 30 | 0 |
| K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | Verathon Medical (Canada) Ulc | 2019-08-21 | 30 | 0 |
| K183256 | GlideScope BFlex Single-Use Bronchoscope System | Verathon Medical (Canada) Ulc | 2019-01-04 | 44 | 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