Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pixxgen Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211108 | Prudent 1717, Prudent 1417, Prudent 1212 | Pixxgen Corporation | 2021-06-04 | 51 | 0 |
| K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor Panel | Pixxgen Corporation | 2019-04-04 | 17 | 0 |
| K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Re | Pixxgen Corporation | 2018-10-04 | 20 | 0 |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Re | Pixxgen Corporation | 2018-05-24 | 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