United Sonics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “United Sonics, Inc.” (first 1985, latest 1985), across 1 product code in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent United Sonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851211 | PHACO PAK I | HQC | 1985-06-05 | 71 |
| K851298 | MID LABS MVSXI | HQC | 1985-05-31 | 66 |
| K851212 | UNITED SONICS PACO SYSTEM MODEL 3000 | HQC | 1985-05-31 | 66 |
| K851210 | UNITED SONICS PHACO MODULE, DF-35 | HQC | 1985-05-31 | 66 |
| K851209 | CILCO/UNITED SONICS PHACE PF-9000 | HQC | 1985-05-31 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named United Sonics, 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.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Consortium (15 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Sonics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “United Sonics, Inc.” (first 1985, latest 1985), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by United Sonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Sonics, Inc. is 66 days.
Which FDA product codes appear under United Sonics, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 5).
Next steps
- See all 5 United Sonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, United Sonics, 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.