Teratech Corp.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Teratech Corp.” (first 1999, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 17 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 |
|---|---|---|
| 2012 | 1 | 122 |
| 2013 | 1 | 25 |
| 2014 | 3 | 23 |
| 2015 | 2 | 48 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 28 |
| 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 Teratech Corp. took a median 28 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 13 | 13 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Review panels
- Radiology (19)
Most recent Teratech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201633 | Terason uSmart 3200T Plus Ultrasound System | IYN | 2020-07-02 | 16 |
| K193510 | Terason uSmart3200T Ultrasound System | IYN | 2020-01-28 | 41 |
| K150533 | Terason uSmart3200T Ultrasound System | IYN | 2015-05-09 | 68 |
| K150148 | Terason uSmart3300 Ultrasound System | IYN | 2015-02-20 | 28 |
| K140773 | TERASON USMART3300 ULTRASOUND SYSTEM | IYN | 2014-05-30 | 63 |
| K140834 | TERASON USMART3400 ULTRASOUND SYSTEM | IYN | 2014-04-25 | 23 |
| K140524 | TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM | IYN | 2014-03-21 | 17 |
| K131209 | TERASON USMART3200T ULTRASOUND SYSTEM | IYN | 2013-05-24 | 25 |
| K112953 | TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS | IYN | 2012-02-03 | 122 |
| K110482 | PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS | IYN | 2011-03-18 | 28 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Teratech Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Teratech Corp.?
FDA lists 19 510(k) clearances under the applicant name “Teratech Corp.” (first 1999, latest 2020), across 3 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 Teratech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teratech Corp. is 17 days.
Which FDA product codes appear under Teratech Corp.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 13); ITX (Transducer, Ultrasonic, Diagnostic, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 19 Teratech Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Teratech Corp.'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.