Verathon Medical (Canada) Ulc: FDA clearances and approvals
Verathon Medical (Canada) Ulc has 6 FDA 510(k) clearances (first 2019, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 37 days. Since 2017 its median was 37 days, against 145 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 37 |
| 2020 | 1 | 30 |
| 2021 | 1 | 133 |
| 2022 | 0 | — |
| 2023 | 1 | 29 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 171 |
Review time against the same product codes
Since 2017, Verathon Medical (Canada) Ulc's cleared 510(k)s took a median 37 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 5 | 5 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent Verathon Medical (Canada) Ulc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) | FAJ | 2026-05-11 | 171 |
| K230948 | BFlex 2 Slim 3.8 Single-Use Bronchoscope | EOQ | 2023-05-03 | 29 |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | EOQ | 2021-11-03 | 133 |
| K193488 | GlideScope BFlex 3.8 Single-Use Bronchoscope | EOQ | 2020-01-16 | 30 |
| K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | EOQ | 2019-08-21 | 30 |
| K183256 | GlideScope BFlex Single-Use Bronchoscope System | EOQ | 2019-01-04 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Verathon Medical (Canada) Ulc.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Verathon Medical (Canada) Ulc have?
Verathon Medical (Canada) Ulc has 6 FDA 510(k) clearances (first 2019, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear Verathon Medical (Canada) Ulc's 510(k)s?
The median time from FDA receipt to decision across Verathon Medical (Canada) Ulc's cleared 510(k)s is 37 days. Since 2017: 37 days, versus 145 days for all cleared 510(k)s in the same product codes.
What devices does Verathon Medical (Canada) Ulc make?
Its most frequent FDA product codes are EOQ (Bronchoscope (Flexible Or Rigid), 5); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Has Verathon Medical (Canada) Ulc had device recalls?
openFDA lists no recalls under a recalling firm name matching Verathon Medical (Canada) Ulc. Related entities may recall under other names.
Next steps
- See all 6 Verathon Medical (Canada) Ulc clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Verathon Medical (Canada) Ulc's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.