Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Controlrad, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
186 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213455 | ControlRad Select Model Z | Controlrad, Inc. | 2021-11-24 | 29 | 0 |
| K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, Control | Controlrad, Inc. | 2021-07-01 | 22 | 0 |
| K202431 | ControlRad Select Model Z | Controlrad, Inc. | 2020-12-23 | 120 | 0 |
| K200663 | ControlRad Trace Model 9 | Controlrad, Inc. | 2020-06-24 | 103 | 0 |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | 2020-04-26 | 86 | 0 |
| K183109 | ControlRad Trace Model 8 | Controlrad, Inc. | 2019-05-13 | 186 | 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