Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innotron Diagnostics — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
35 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850629 | INNOFLUOR THEOPHYLLINE | Innotron Diagnostics | 1985-03-12 | 21 | 0 |
| K844721 | INNOFLUOR PRIMIDONE | Innotron Diagnostics | 1985-01-08 | 35 | 0 |
| K841865 | INNOFLOUR GENTAMICIN | Innotron Diagnostics | 1984-05-31 | 27 | 0 |
| K841866 | INNOFLOUR TOBRAMYCIN | Innotron Diagnostics | 1984-05-31 | 27 | 0 |
| K841707 | INNOFLUOR PHENOBARBITAL | Innotron Diagnostics | 1984-05-23 | 30 | 0 |
| K841706 | INNOFLUOR PHENYTOIN | Innotron Diagnostics | 1984-05-22 | 29 | 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