Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QBS · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
185 daysmedian FDA review time
237 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260378 | Rayvolve | AZmed | 2026-05-12 | 96 | 0 |
| K242171 | TechCare Trauma | Milvue | 2025-01-17 | 177 | 0 |
| K240712 | icobrain aria | Icometrix NV | 2024-11-07 | 237 | 0 |
| K240845 | Rayvolve | Azmed Sas | 2024-07-17 | 112 | 0 |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm | Ge Medical Systems, LLC | 2023-05-25 | 185 | 0 |
| K222176 | BoneView | Gleamer | 2023-03-02 | 223 | 0 |
| K220164 | Rayvolve | Azmed Sas | 2022-06-02 | 133 | 0 |
| K212365 | BoneView | Gleamer | 2022-03-01 | 214 | 0 |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 | 234 | 0 |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018-05-24 | 108 | 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