Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Germiphene Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
609 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983847 | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT | Germiphene Corp. | 1998-12-01 | 32 | 0 |
| K961289 | VAPOPHENE | Germiphene Corp. | 1997-12-04 | 609 | 0 |
| K964796 | ODYSSEY I DENTAL WATER UNIT | Germiphene Corp. | 1997-05-14 | 166 | 0 |
| K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | Germiphene Corp. | 1994-11-04 | 141 | 0 |
| K894933 | PERLIDENT | Germiphene Corp. | 1989-10-12 | 70 | 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