Koelis: FDA clearances and approvals
Koelis has 7 FDA 510(k) clearances (first 2010, latest 2018), across 3 product codes in 1 review panel. Median 510(k) review time: 88 days. Since 2017 its median was 97 days, against 112 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 67 |
| 2014 | 1 | 51 |
| 2015 | 0 | — |
| 2016 | 1 | 84 |
| 2017 | 2 | 106 |
| 2018 | 1 | 88 |
| 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, Koelis's cleared 510(k)s took a median 97 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (7)
Most recent Koelis 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180970 | Disposable guides KDNG00 | ITX | 2018-07-10 | 88 |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | ITX | 2017-07-31 | 116 |
| K170521 | TRINITY/3D PROSTATE SUITE | IYN | 2017-05-30 | 97 |
| K160357 | TRINITY | IYN | 2016-05-02 | 84 |
| K141334 | REUSABLE GUIDE | ITX | 2014-07-11 | 51 |
| K131448 | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION | LLZ | 2013-07-26 | 67 |
| K100793 | UROSTATION 3D PROSTATE SUITE | LLZ | 2010-09-22 | 184 |
Recalls
openFDA lists no recalls under a recalling firm named Koelis.
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.
Device clinical trials
Koelis is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04582656: Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer (Completed, started 2021-02-11)
Frequently asked questions
How many FDA 510(k) clearances does Koelis have?
Koelis has 7 FDA 510(k) clearances (first 2010, latest 2018), across 3 product codes in 1 review panel.
How long does FDA take to clear Koelis's 510(k)s?
The median time from FDA receipt to decision across Koelis's cleared 510(k)s is 88 days. Since 2017: 97 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Koelis make?
Its most frequent FDA product codes are ITX (Transducer, Ultrasonic, Diagnostic, 3); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2); LLZ (System, Image Processing, Radiological, 2).
Has Koelis had device recalls?
openFDA lists no recalls under a recalling firm name matching Koelis. Related entities may recall under other names.
Next steps
- See all 7 Koelis clearances with predicates and recalls
- Run predicate analysis for product code ITX, Koelis'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.