Medisonic U.S.A., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medisonic U.S.A., Inc.” (first 1989, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 109 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| NFB | Conserver, Oxygen | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (1)
Most recent Medisonic U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924577 | MEDIVAC | GCX | 1993-03-23 | 194 |
| K923660 | MEDISONIC OXYGEN FLOW CONTROLLER | NFB | 1993-01-27 | 189 |
| K901114 | MEDISONIC HUMDIFIER/INHALER | CAF | 1990-05-22 | 76 |
| K896192 | MEDISONIC PNEU-NEB | CAF | 1990-01-03 | 70 |
| K894961 | MEDISONIC ULTRA-SONIC INHALER | CAF | 1989-11-24 | 109 |
Recalls
openFDA lists no recalls under a recalling firm named Medisonic U.S.A., 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medisonic U.S.A., Inc. (a text match, not an official crosswalk):
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.
- Medisonic Technology CO (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medisonic U.S.A., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medisonic U.S.A., Inc.” (first 1989, latest 1993), 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 Medisonic U.S.A., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medisonic U.S.A., Inc. is 109 days.
Which FDA product codes appear under Medisonic U.S.A., Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 3); GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 1); NFB (Conserver, Oxygen, 1).
Next steps
- See all 5 Medisonic U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Medisonic U.S.A., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.