Sonosite,Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Sonosite,Inc.” (first 1998, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 15 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.
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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 16 | 16 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| OMF | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position | 1 | 1 |
Review panels
- Radiology (21)
- Cardiovascular (1)
- General Hospital (1)
Most recent Sonosite,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | IYO | 2011-11-15 | 20 |
| K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | DSB | 2011-06-03 | 91 |
| K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | 2010-11-19 | 88 |
| K093510 | LUMENVU CATHETER GUIDANCE SYSTEM | OMF | 2010-08-23 | 284 |
| K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | ITX | 2010-08-12 | 50 |
| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | 2009-10-02 | 86 |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | 2008-08-25 | 31 |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2007-05-08 | 15 |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | 2005-11-16 | 15 |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | IYN | 2005-08-11 | 7 |
13 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2013-09-11.
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 Sonosite,Inc.?
FDA lists 23 510(k) clearances under the applicant name “Sonosite,Inc.” (first 1998, latest 2011), across 5 product codes in 3 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 Sonosite,Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonosite,Inc. is 15 days.
Which FDA product codes appear under Sonosite,Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 16); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 23 Sonosite,Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Sonosite,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.