Sonotech, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Sonotech, Inc.” (first 1995, latest 2004), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 102 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 | 8 | 8 |
| MUI | Media, Coupling, Ultrasound | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (13)
- General and Plastic Surgery (1)
Most recent Sonotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | MUI | 2004-11-05 | 42 |
| K033178 | ULTRABIO | MUI | 2004-08-04 | 308 |
| K031222 | SCANLUBE | MUI | 2003-07-23 | 97 |
| K031894 | SCANTEC PAD | MUI | 2003-07-18 | 29 |
| K013701 | ENDO-GLIDE | GCJ | 2002-02-04 | 88 |
| K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP | ITX | 2001-11-13 | 50 |
| K984562 | VIVOSONIC | ITX | 1999-06-08 | 167 |
| K983691 | SCANFLEX SOLID COUPLANT MEMBRANE | ITX | 1999-05-05 | 197 |
| K983985 | HYBRISONIC SHEATH | ITX | 1999-02-25 | 108 |
| K981028 | ULTRA IMAGE AND ULTRA SCAN | ITX | 1998-08-21 | 155 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sonotech, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonotech, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Sonotech, Inc.” (first 1995, latest 2004), across 4 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 Sonotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonotech, Inc. is 102 days.
Which FDA product codes appear under Sonotech, Inc.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 8); MUI (Media, Coupling, Ultrasound, 4); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 14 Sonotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Sonotech, 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.