Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorad Corp. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
155 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992280 | LORAD 1-650 (INTERNATIONAL 650) | Lorad Corp. | 1999-09-03 | 58 | 0 |
| K974460 | LITE TOUCH ERBIUM LASER TREATMENT SYSTEM | Lorad Corp. | 1998-01-16 | 52 | 0 |
| K973631 | LORAD M-III ELITE (M-III E) | Lorad Corp. | 1997-12-23 | 90 | 0 |
| K952210 | LORAD STEROLOC II | Lorad Corp. | 1995-07-24 | 75 | 0 |
| K945241 | LORAD M-IV, LORAD M-IVI | Lorad Corp. | 1995-03-31 | 155 | 0 |
| K950608 | DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION | Lorad Corp. | 1995-03-02 | 21 | 0 |
| K945496 | MAMMOGRAPHIC X-RAY UNIT | Lorad Corp. | 1994-12-27 | 49 | 0 |
| K945272 | RHODIUM FILTER | Lorad Corp. | 1994-12-14 | 47 | 0 |
| K934868 | LORAD TRANSPO | Lorad Corp. | 1994-10-14 | 367 | 0 |
| K934870 | LORAD D-550 | Lorad Corp. | 1994-01-31 | 111 | 0 |
| K934748 | LORAD M-IIE MODIFICATION | Lorad Corp. | 1994-01-31 | 119 | 0 |
| K934625 | LORAD M-III | Lorad Corp. | 1994-01-28 | 123 | 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