Delphinus Medical Technologies: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Delphinus Medical Technologies” (first 2013, latest 2018), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 219 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 |
|---|---|---|
| 2013 | 1 | 433 |
| 2014 | 1 | 53 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 219 |
| 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 Delphinus Medical Technologies took a median 219 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 | 3 | 3 |
| PAA | Automated Breast Ultrasound | 1 | 0 |
Review panels
- Radiology (4)
Most recent Delphinus Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172256 | SoftVue | IYO | 2018-03-02 | 219 |
| K142517 | SoftVue | IYO | 2014-10-31 | 53 |
| K123209 | SOFTVUE | IYO | 2013-12-19 | 433 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200040 | PMA | SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly | 2021-10-06 |
Recalls
openFDA lists no recalls under a recalling firm named Delphinus Medical Technologies.
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 Delphinus Medical Technologies is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04260620: Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3) (Completed, started 2020-02-08)
- NCT03972605: Delphinus SoftVue™ ROC Reader Study (Completed, started 2019-06-08)
- NCT03698942: Delphinus SoftVue™ ROC Reader Study (Completed, started 2018-09-23)
- NCT03257839: Delphinus SoftVue Prospective Case Collection - ARM 1 (Completed, started 2017-07-31)
- NCT02977247: Delphinus SoftVue Prospective Case Collection - ARM 2 (Completed, started 2016-12-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Delphinus Medical Technologies?
FDA lists 3 510(k) clearances under the applicant name “Delphinus Medical Technologies” (first 2013, latest 2018), plus 1 PMA decision, across 2 product codes 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 Delphinus Medical Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Delphinus Medical Technologies is 219 days.
Which FDA product codes appear under Delphinus Medical Technologies?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); PAA (Automated Breast Ultrasound, 1).
Next steps
- See all 3 Delphinus Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code IYO, Delphinus Medical Technologies'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.