Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radmedix, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
112 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231995 | AcuityUDR | Radmedix, LLC | 2023-10-25 | 112 | 0 |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | 2023-07-12 | 30 | 0 |
| K210919 | AcuityDRe | Radmedix, LLC | 2021-04-30 | 32 | 0 |
| K201058 | Accuvue+ | Radmedix, LLC | 2020-05-06 | 15 | 0 |
| K200726 | AcuityPDR | Radmedix, LLC | 2020-04-13 | 24 | 0 |
| K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | Radmedix, LLC | 2020-01-02 | 29 | 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