Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Regulatory Insight, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140780 | KEGEL SMART, KEGELSMART PEARL | Regulatory Insight, Inc. | 2014-09-10 | 166 | 0 |
| K112505 | ETHEREA | Regulatory Insight, Inc. | 2012-04-06 | 220 | 0 |
| K020094 | EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, | Regulatory Insight, Inc. | 2002-03-08 | 56 | 0 |
| K020100 | SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND S | Regulatory Insight, Inc. | 2002-03-08 | 56 | 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