Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carestream Health · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
298 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-R | Carestream Health | 2026-03-11 | 166 | 0 |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray Sy | Carestream Health | 2026-01-20 | 298 | 0 |
| K213568 | DRX-Rise Mobile X-ray System | Carestream Health | 2022-03-23 | 134 | 0 |
| K203159 | Lux 35 Detector | Carestream Health | 2020-12-02 | 40 | 0 |
| K163157 | SmartGrid | Carestream Health | 2017-03-21 | 131 | 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