Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pearl, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
224 daysmedian FDA review time
389 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025-11-14 | 266 | 0 |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 | 245 | 0 |
| K243989 | Second Opinion® 3D | Pearl, Inc. | 2025-05-23 | 148 | 0 |
| K243230 | Second Opinion® BLE | Pearl, Inc. | 2025-05-09 | 213 | 0 |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 | 138 | 0 |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025-04-11 | 224 | 0 |
| K242522 | Second Opinion CC | Pearl, Inc. | 2025-01-16 | 146 | 0 |
| K210365 | Second Opinion | Pearl, Inc. | 2022-03-04 | 389 | 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