Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innova Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
784 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040714 | HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT | Innova Corp. | 2004-04-09 | 22 | 0 |
| K984117 | INNOVA TELESCOPIC DISTRACTOR | Innova Corp. | 1999-02-10 | 85 | 0 |
| K971196 | ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Innova Corp. | 1997-05-08 | 38 | 0 |
| K952434 | ENDOPORE DENTAL IMPLANT ABUTMENTS | Innova Corp. | 1995-07-19 | 56 | 0 |
| K926354 | ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Innova Corp. | 1995-02-13 | 784 | 0 |
| K915361 | THE BODY BUGGY | Innova Corp. | 1991-12-20 | 23 | 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