Tetra Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tetra Corp.” (first 1993, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 191 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
Review panels
- Radiology (5)
Most recent Tetra Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946277 | TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM | IYN | 1996-03-15 | 444 |
| K945320 | TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL | ITX | 1995-05-11 | 191 |
| K945318 | TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA | ITX | 1995-05-05 | 185 |
| K945319 | TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT | ITX | 1995-05-04 | 184 |
| K924204 | NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS | IYN | 1993-06-07 | 291 |
Recalls
openFDA lists no recalls under a recalling firm named Tetra 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tetra Group U.S.A., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tetra Corp.?
FDA lists 5 510(k) clearances under the applicant name “Tetra Corp.” (first 1993, latest 1996), across 2 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 Tetra Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tetra Corp. is 191 days.
Which FDA product codes appear under Tetra Corp.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 3); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2).
Next steps
- See all 5 Tetra Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Tetra 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.