Med USA: FDA clearances and approvals
Med USA has 5 FDA 510(k) clearances (first 1985, latest 1990), across 4 product codes in 3 review panels. Median 510(k) review time: 103 days.
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 |
|---|---|---|---|
| KQG | Instrument, Coagulation | 2 | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 1 | 1 |
Review panels
- Hematology (3)
- Anesthesiology (1)
- Neurology (1)
Most recent Med USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896766 | TD-28 DISPOSABLE ELECTRODE | GXY | 1990-03-14 | 103 |
| K862047 | COAGULATOR (8 CHANNEL) | KQG | 1986-09-29 | 123 |
| K852492 | COAGULATOR | KQG | 1985-08-13 | 62 |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | KFZ | 1985-06-05 | 103 |
| K841803 | A1 SYSTEME 8201/2 | GKL | 1985-02-25 | 300 |
Recalls
openFDA lists no recalls under a recalling firm named Med USA.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Med USA have?
Med USA has 5 FDA 510(k) clearances (first 1985, latest 1990), across 4 product codes in 3 review panels.
How long does FDA take to clear Med USA's 510(k)s?
The median time from FDA receipt to decision across Med USA's cleared 510(k)s is 103 days.
What devices does Med USA make?
Its most frequent FDA product codes are KQG (Instrument, Coagulation, 2); GKL (Counter, Cell, Automated (Particle Counter), 1); GXY (Electrode, Cutaneous, 1).
Has Med USA had device recalls?
openFDA lists no recalls under a recalling firm name matching Med USA. Related entities may recall under other names.
Next steps
- See all 5 Med USA clearances with predicates and recalls
- Run predicate analysis for product code KQG, Med USA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.