Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radformation, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
206 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | 2026-04-03 | 113 | 0 |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | 2026-03-19 | 30 | 0 |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 2026-01-05 | 109 | 0 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 | 101 | 0 |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | 2024-12-09 | 90 | 0 |
| K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023-04-14 | 32 | 0 |
| K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022-08-24 | 175 | 0 |
| K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022-08-23 | 175 | 0 |
| K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | 2022-08-22 | 174 | 0 |
| K200323 | AutoContour | Radformation, Inc. | 2020-10-30 | 263 | 0 |
| K201119 | ChartCheck | Radformation, Inc. | 2020-06-26 | 60 | 0 |
| K193640 | ClearCalc | Radformation, Inc. | 2020-04-09 | 104 | 0 |
| K171352 | EZFluence | Radformation, Inc. | 2017-12-01 | 206 | 0 |
| K171350 | Collision Check | Radformation, Inc. | 2017-11-29 | 204 | 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