Interson Corp.: FDA clearances and approvals
Interson Corp. has 11 FDA 510(k) clearances (first 1989, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time: 177 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 126 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Interson Corp.'s cleared 510(k)s took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 6 | 6 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| FCG | Biopsy Needle | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
Most recent Interson Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233734 | Interson USB Ultrasound System | IYN | 2023-12-22 | 30 |
| K163443 | Interson USB Ultrasound System | IYN | 2017-04-13 | 126 |
| K911116 | INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST | ITX | 1991-12-20 | 288 |
| K911117 | INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST | ITX | 1991-12-17 | 285 |
| K911115 | INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM | ITX | 1991-12-17 | 285 |
| K911113 | INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST | ITX | 1991-12-17 | 285 |
| K911114 | INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM | ITX | 1991-11-19 | 257 |
| K911464 | INTERSON DISPOSABLE BIOPSY NEEDLE | IYO | 1991-09-27 | 177 |
| K900555 | INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA. | ITX | 1990-05-02 | 85 |
| K896680 | PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. | FED | 1990-02-14 | 79 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Interson Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances does Interson Corp. have?
Interson Corp. has 11 FDA 510(k) clearances (first 1989, latest 2023), across 5 product codes in 2 review panels.
How long does FDA take to clear Interson Corp.'s 510(k)s?
The median time from FDA receipt to decision across Interson Corp.'s cleared 510(k)s is 177 days.
What devices does Interson Corp. make?
Its most frequent FDA product codes are ITX (Transducer, Ultrasonic, Diagnostic, 6); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2); FCG (Biopsy Needle, 1).
Has Interson Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Interson Corp. Related entities may recall under other names.
Next steps
- See all 11 Interson Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Interson Corp.'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.