Veran Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Veran Medical Technologies, Inc.” (first 2006, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 132 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Olympus, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 157 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 132 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 185 |
| 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 Veran Medical Technologies, Inc. took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 6 | 6 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
- Radiology (6)
- Ear, Nose and Throat (1)
Most recent Veran Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202346 | SPiN Vision Video Bronchoscope System | EOQ | 2021-02-19 | 185 |
| K170023 | SPiN Thoracic Navigation System | JAK | 2017-05-15 | 132 |
| K122106 | SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE | JAK | 2012-12-21 | 157 |
| K093995 | IG 4 IMAGE GUIDED SYSTEM | JAK | 2010-01-27 | 30 |
| K091934 | IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 | JAK | 2009-12-02 | 155 |
| K093146 | IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 | JAK | 2009-11-30 | 56 |
| K060903 | IG4 IMAGE GUIDED SYSTEM | JAK | 2006-05-11 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Veran Medical Technologies, Inc..
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.
Device clinical trials
An industry sponsor named Veran Medical Technologies, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03338049: All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules (Completed, started 2018-02-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Veran Medical Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Veran Medical Technologies, Inc.” (first 2006, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Veran Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Veran Medical Technologies, Inc. is 132 days.
Which FDA product codes appear under Veran Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 6); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 7 Veran Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Veran Medical Technologies, Inc.'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.