Omnisonics Medical Technologies: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Omnisonics Medical Technologies” (first 1999, latest 2008), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 4 | 4 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GCM | Endoscope, Rigid | 1 | 1 |
Review panels
Most recent Omnisonics Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083335 | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM | QEY | 2008-12-15 | 33 |
| K071762 | OMNIWAVE ENDOVASCULAR SYSTEM | QEY | 2007-09-27 | 90 |
| K052428 | RESOLUTION ENDOVASCULAR SYSTEM | QEY | 2005-12-08 | 97 |
| K041705 | RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 | QEY | 2004-09-01 | 70 |
| K003824 | OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI | LFL | 2001-03-08 | 87 |
| K993628 | OMNISONICS ULTRASONIC PROBES | LFL | 1999-12-15 | 49 |
| K993445 | OMNISONIC ENDOSCOPIC DEFLECTOR | GCM | 1999-12-06 | 55 |
| K991377 | OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER | GCJ | 1999-07-12 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Omnisonics Medical Technologies.
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 Omnisonics Medical Technologies?
FDA lists 8 510(k) clearances under the applicant name “Omnisonics Medical Technologies” (first 1999, latest 2008), across 4 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 Omnisonics Medical Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omnisonics Medical Technologies is 76 days.
Which FDA product codes appear under Omnisonics Medical Technologies?
The most frequent FDA product codes under this applicant name are QEY (Mechanical Thrombolysis Catheter, 4); LFL (Instrument, Ultrasonic Surgical, 2); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 8 Omnisonics Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code QEY, Omnisonics Medical Technologies'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.