Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Us Medical Innovations, LLC · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
449 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-10 | Us Medical Innovations, LLC | 2024-05-03 | 92 | 0 |
| K212736 | Canady Flex RoboWrist | Us Medical Innovations, LLC | 2022-11-22 | 449 | 0 |
| K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with A | Us Medical Innovations, LLC | 2019-11-21 | 107 | 0 |
| K113500 | CANADY VIEIRA HYBRID PLASMA SCALPEL | Us Medical Innovations, LLC | 2011-12-09 | 14 | 0 |
| K100669 | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PRO | Us Medical Innovations, LLC | 2011-04-06 | 393 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda