U.S. Medical Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “U.S. Medical Corp.” (first 1980, latest 1994), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| FRW | Scale, Patient | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| INF | Scale, Platform, Wheelchair | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KOE | Dilator, Urethral | 1 | 1 |
Review panels
Most recent U.S. Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934677 | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE | FMT | 1994-07-05 | 280 |
| K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE | KOE | 1993-05-26 | 267 |
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | INF | 1993-02-12 | 164 |
| K910583 | U.S. MEDICAL PS-3000 NEONATAL SCALE | FRW | 1991-03-21 | 38 |
| K910582 | U.S. MEDICAL PS-2000 PEDIATRIC SCALE | FRW | 1991-03-21 | 38 |
| K910581 | U.S. MEDICAL PS-1000 PEDIATRIC SCALE | FRW | 1991-03-21 | 38 |
| K896633 | AUTO-CUFF(TM) | DXN | 1990-02-01 | 71 |
| K801053 | PULSED GALVANIC STIMULATOR, 450-DYNAMAX | IPF | 1980-06-04 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named U.S. Medical Corp..
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 U.S. Medical Corp.?
FDA lists 8 510(k) clearances under the applicant name “U.S. Medical Corp.” (first 1980, latest 1994), across 6 product codes in 4 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 U.S. Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U.S. Medical Corp. is 54 days.
Which FDA product codes appear under U.S. Medical Corp.?
The most frequent FDA product codes under this applicant name are FRW (Scale, Patient, 3); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1); FMT (Warmer, Infant Radiant, 1).
Next steps
- See all 8 U.S. Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRW, U.S. Medical Corp.'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.