Interrad Medical, Inc.: FDA clearances and approvals
Interrad Medical, Inc. has 7 FDA 510(k) clearances (first 2008, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time: 95 days. Since 2017 its median was 95 days, against 142 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 | 1 | 30 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 95 |
| 2019 | 1 | 449 |
| 2020 | 0 | — |
| 2021 | 1 | 41 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Interrad Medical, Inc.'s cleared 510(k)s took a median 95 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OKC | Implanted Subcutaneous Securement Catheter | 5 | 5 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Interrad Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210629 | SecurAcath | OKC | 2021-04-12 | 41 |
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | KMK | 2019-07-09 | 449 |
| K180769 | SecurAcath | OKC | 2018-06-26 | 95 |
| K120935 | SECURACATH | OKC | 2012-04-27 | 30 |
| K092306 | SECURACATH UNIVERSAL | LJS | 2010-07-09 | 345 |
| K083081 | MODIFICATION TO SECURACATH, MODEL: SPK01 | OKC | 2009-03-04 | 139 |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | OKC | 2008-09-30 | 74 |
Recalls
openFDA lists no recalls under a recalling firm named Interrad Medical, Inc..
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
Interrad Medical, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00903539: Prospective SecurAcath Subcutaneous Securement Trial (Completed, started 2009-01)
Frequently asked questions
How many FDA 510(k) clearances does Interrad Medical, Inc. have?
Interrad Medical, Inc. has 7 FDA 510(k) clearances (first 2008, latest 2021), across 3 product codes in 1 review panel.
How long does FDA take to clear Interrad Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Interrad Medical, Inc.'s cleared 510(k)s is 95 days. Since 2017: 95 days, versus 142 days for all cleared 510(k)s in the same product codes.
What devices does Interrad Medical, Inc. make?
Its most frequent FDA product codes are OKC (Implanted Subcutaneous Securement Catheter, 5); KMK (Device, Intravascular Catheter Securement, 1); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 1).
Has Interrad Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Interrad Medical, Inc. Related entities may recall under other names.
Next steps
- See all 7 Interrad Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OKC, Interrad Medical, Inc.'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.