Corindus, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Corindus, Inc.” (first 2012, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 76 days, against 99 days for all cleared 510(k)s in the same product codes. 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 Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 122 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 183 |
| 2016 | 2 | 220 |
| 2017 | 0 | — |
| 2018 | 3 | 76 |
| 2019 | 0 | — |
| 2020 | 1 | 122 |
| 2021 | 0 | — |
| 2022 | 1 | 69 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Corindus, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | 9 | 9 |
Review panels
- Cardiovascular (9)
Most recent Corindus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221464 | CorPath GRX System | DXX | 2022-07-27 | 69 |
| K202275 | CorPath GRX System | DXX | 2020-12-11 | 122 |
| K180517 | CorPath GRX System | DXX | 2018-03-29 | 30 |
| K173806 | CorPath GRX System | DXX | 2018-03-01 | 76 |
| K173288 | CorPath GRX System | DXX | 2018-02-15 | 122 |
| K160121 | CorPath GRX System | DXX | 2016-10-27 | 282 |
| K152999 | CorPath 200 System | DXX | 2016-03-18 | 157 |
| K150892 | CorPath 200 System | DXX | 2015-10-02 | 183 |
| K120834 | CORPATH 200 SYSTEM | DXX | 2012-07-19 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Corindus, 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 Corindus, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04236856: CorPath® GRX Neuro Study (Completed, started 2020-08-21)
- NCT03870087: PRECISION GRX Post-Market Study - Japan (Completed, started 2019-04-12)
- NCT03705481: GRX With ReMOTE: First in Human in India (Completed, started 2018-12-03)
- NCT03278301: PRECISION GRX Registry (Completed, started 2017-08-27)
- NCT02742077: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II (Completed, started 2016-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Corindus, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Corindus, Inc.” (first 2012, latest 2022), 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 Corindus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corindus, Inc. is 122 days. Since 2017: 76 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Corindus, Inc.?
The most frequent FDA product codes under this applicant name are DXX (System, Catheter Control, Steerable, 9).
Next steps
- See all 9 Corindus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXX, Corindus, 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.