Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osko, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
269 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201503 | Edge Air(1417) Digital Flat Panel X-ray Detector | Osko, Inc. | 2020-06-29 | 24 | 0 |
| K172681 | Edge Air Digital Flat Panel X-ray Detector | Osko, Inc. | 2017-10-06 | 30 | 0 |
| K172682 | Edge Digital Flat Panel X-ray Detector | Osko, Inc. | 2017-10-06 | 30 | 0 |
| K163048 | Smart Stitching Software System, Image Processing, Radiologi | Osko, Inc. | 2017-07-28 | 269 | 0 |
| K150663 | Diagnostic X-ray System | Osko, Inc. | 2015-05-07 | 52 | 0 |
| K150506 | ELIAN Digital Diagnostic X-ray System | Osko, Inc. | 2015-04-08 | 41 | 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