Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solar Laboratories, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
9 daysmedian FDA review time
63 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771244 | 2,2DIMETHOXY-2-PHENYLACETOPHENONE | Solar Laboratories, Inc. | 1977-09-12 | 63 | 0 |
| K770134 | LIGHTCAST II STOCKINETTE | Solar Laboratories, Inc. | 1977-01-26 | 5 | 0 |
| K770133 | LIGHTCAST II CASTING SYSTEM (MODIFIED) | Solar Laboratories, Inc. | 1977-01-26 | 5 | 0 |
| K761222 | BENZOIN ISOBUTYL ETHER | Solar Laboratories, Inc. | 1976-12-16 | 9 | 0 |
| K760413 | TAPE, LIGHTCAST II WB | Solar Laboratories, Inc. | 1976-08-23 | 14 | 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