Verathon Incorporated: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Verathon Incorporated” (first 2007, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 43 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 24 |
| 2016 | 0 | — |
| 2017 | 1 | 43 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Verathon Incorporated took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
Review panels
- Radiology (5)
Most recent Verathon Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172356 | BladderScan Prime PLUS System | IYO | 2017-09-15 | 43 |
| K153101 | BladderScan Prime System | IYO | 2015-11-19 | 24 |
| K090214 | VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND | IYO | 2009-03-13 | 43 |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | IYO | 2008-12-01 | 97 |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | IYO | 2007-05-17 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Verathon Incorporated.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Verathon Medical (Canada) Ulc (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Verathon Incorporated?
FDA lists 5 510(k) clearances under the applicant name “Verathon Incorporated” (first 2007, latest 2017), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Verathon Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Verathon Incorporated is 43 days.
Which FDA product codes appear under Verathon Incorporated?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5).
Next steps
- See all 5 Verathon Incorporated clearances with predicates and recalls
- Run predicate analysis for product code IYO, Verathon Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.