Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hofmann X-Ray of America, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893690 | SUPER SPEED POTTER-BUCKY (ESO5-110 & 220) | Hofmann X-Ray of America, Inc. | 1989-07-20 | 65 | 0 |
| K851011 | HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR | Hofmann X-Ray of America, Inc. | 1985-04-10 | 29 | 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