Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorvic Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
137 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871615 | U. V. GERMICIDAL UNIT | Lorvic Corp. | 1987-09-11 | 137 | 0 |
| K780263 | SHIELD | Lorvic Corp. | 1978-05-03 | 75 | 0 |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Lorvic Corp. | 1977-01-14 | 3 | 0 |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Lorvic Corp. | 1977-01-14 | 3 | 0 |
| K760620 | SALIVA EJECTOR | Lorvic Corp. | 1976-09-21 | 8 | 0 |
| K760121 | IMPULSE HEAT SEALER | Lorvic Corp. | 1976-07-16 | 18 | 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