Us Medical Innovations, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Us Medical Innovations, LLC” (first 2011, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 107 days. Since 2017 the median was 107 days, against 107 days for all cleared 510(k)s in the same product codes. 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 | 1 | 107 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 449 |
| 2023 | 0 | — |
| 2024 | 1 | 92 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Us Medical Innovations, LLC took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| OAB | Low Energy Direct Current Thermal Ablation System | 1 | 1 |
Review panels
Most recent Us Medical Innovations, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | OAB | 2024-05-03 | 92 |
| K212736 | Canady Flex RoboWrist | GCJ | 2022-11-22 | 449 |
| K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | GEI | 2019-11-21 | 107 |
| K113500 | CANADY VIEIRA HYBRID PLASMA SCALPEL | GEI | 2011-12-09 | 14 |
| K100669 | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES | GEI | 2011-04-06 | 393 |
Recalls
openFDA lists no recalls under a recalling firm named Us Medical Innovations, LLC.
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 Us Medical Innovations, LLC?
FDA lists 5 510(k) clearances under the applicant name “Us Medical Innovations, LLC” (first 2011, latest 2024), across 3 product codes 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 Us Medical Innovations, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Us Medical Innovations, LLC is 107 days. Since 2017: 107 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Us Medical Innovations, LLC?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); GCJ (Laparoscope, General & Plastic Surgery, 1); OAB (Low Energy Direct Current Thermal Ablation System, 1).
Next steps
- See all 5 Us Medical Innovations, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Us Medical Innovations, LLC'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.