Sonomed, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sonomed, Inc.” (first 1992, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 | 1 | 64 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 19 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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 Sonomed, Inc. took a median 19 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 6 | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| NFJ | System, Image Management, Ophthalmic | 1 | 1 |
Review panels
- Radiology (7)
- Ophthalmic (1)
Most recent Sonomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171098 | AXIS Image Management System | NFJ | 2017-05-02 | 19 |
| K140199 | VUPAD | IYO | 2014-04-01 | 64 |
| K100252 | MASTER-VU A-SCAN, MV4500 | IYO | 2010-04-09 | 71 |
| K092637 | PACSCAN PLUS, MODELS 300P AND 300AP | ITX | 2009-09-24 | 28 |
| K073196 | MASTER-VU | IYO | 2007-12-19 | 36 |
| K060626 | VUMAX | IYO | 2006-04-11 | 33 |
| K040668 | E-Z SCAN AB5500+ | IYO | 2004-04-13 | 29 |
| K924311 | SONOMED 4000P ULTRASONIC PACHYMETER | IYO | 1992-12-08 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Sonomed, Inc..
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.
- Sonomed Technology, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonomed, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Sonomed, Inc.” (first 1992, latest 2017), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sonomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonomed, Inc. is 34 days.
Which FDA product codes appear under Sonomed, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 6); ITX (Transducer, Ultrasonic, Diagnostic, 1); NFJ (System, Image Management, Ophthalmic, 1).
Next steps
- See all 8 Sonomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Sonomed, Inc.'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.