Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovators, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
189 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921355 | WINGMASTER | Innovators, Inc. | 1992-09-25 | 189 | 0 |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Innovators, Inc. | 1992-09-25 | 189 | 0 |
| K921406 | SILICONT BUR BLOCK | Innovators, Inc. | 1992-04-28 | 39 | 0 |
| K844351 | OPTI-LITE | Innovators, Inc. | 1984-12-21 | 42 | 0 |
| K830042 | E-Z JECTOR | Innovators, Inc. | 1983-01-26 | 19 | 0 |
| K790984 | KLIP-LITE | Innovators, Inc. | 1979-10-22 | 150 | 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