Sonomed Technology, Inc.: FDA clearances and approvals
Sonomed Technology, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time: 219 days.
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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Radiology (5)
Most recent Sonomed Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931909 | CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL | IYO | 1994-09-29 | 531 |
| K931908 | SONOQUICK ULTRASOUND GEL | IYO | 1994-09-29 | 531 |
| K883917 | NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT | IYO | 1989-03-31 | 196 |
| K844031 | SONOMED TECH OPHTHALMIC B-SCAN B-3000 | ITX | 1985-05-22 | 219 |
| K843696 | OPHTHALMIC A-SCAN A-2000 SONOME | IYO | 1985-02-26 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Sonomed Technology, 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.
Frequently asked questions
How many FDA 510(k) clearances does Sonomed Technology, Inc. have?
Sonomed Technology, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1994), across 2 product codes in 1 review panel.
How long does FDA take to clear Sonomed Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sonomed Technology, Inc.'s cleared 510(k)s is 219 days.
What devices does Sonomed Technology, Inc. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Has Sonomed Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sonomed Technology, Inc. Related entities may recall under other names.
Next steps
- See all 5 Sonomed Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Sonomed Technology, 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.