Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Innotron of Oregon, Inc. · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
67 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET | Innotron of Oregon, Inc. | 1990-08-22 | 40 | 0 |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Innotron of Oregon, Inc. | 1990-08-09 | 27 | 0 |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-20 | 67 | 0 |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-19 | 66 | 0 |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | Innotron of Oregon, Inc. | 1990-04-12 | 59 | 0 |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-12 | 59 | 0 |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | Innotron of Oregon, Inc. | 1990-04-12 | 59 | 0 |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-12 | 59 | 0 |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | Innotron of Oregon, Inc. | 1990-04-12 | 59 | 0 |
| K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | Innotron of Oregon, Inc. | 1989-10-31 | 29 | 0 |
| K895826 | INNOFLUOR DIGOXIN CALIBRATOR SET | Innotron of Oregon, Inc. | 1989-10-30 | 28 | 0 |
| K895828 | INNOFLUOR DIGOXIN REAGENT SET | Innotron of Oregon, Inc. | 1989-10-30 | 28 | 0 |
| K893506 | INNOFLUOR CARBAMAZEPINE CALIBRATOR SET | Innotron of Oregon, Inc. | 1989-08-15 | 102 | 0 |
| K893507 | INNOFLUOR CARBAMAZEPINE REAGENT SET | Innotron of Oregon, Inc. | 1989-08-11 | 98 | 0 |
| K892208 | INNOFLUOR(TM) QUINIDINE REAGENT SET | Innotron of Oregon, Inc. | 1989-06-09 | 67 | 0 |
| K892212 | INNOFLUOR(TM) QUINDINE CALIBATOR SET | Innotron of Oregon, Inc. | 1989-06-09 | 67 | 0 |
| K872563 | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET | Innotron of Oregon, Inc. | 1987-08-21 | 58 | 0 |
| K872562 | INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET | Innotron of Oregon, Inc. | 1987-08-17 | 54 | 0 |
| K872579 | INNOFLUOR VANCOMYCIN REAGENT SET | Innotron of Oregon, Inc. | 1987-08-17 | 48 | 0 |
| K872142 | INNOFLUOR PHENYTOIN CALIBRATOR SET | Innotron of Oregon, Inc. | 1987-07-21 | 48 | 0 |
| K872349 | INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET | Innotron of Oregon, Inc. | 1987-07-21 | 48 | 1 |
| K872461 | INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET | Innotron of Oregon, Inc. | 1987-07-21 | 27 | 0 |
| K872462 | INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET | Innotron of Oregon, Inc. | 1987-07-21 | 29 | 0 |
| K872463 | INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET | Innotron of Oregon, Inc. | 1987-07-21 | 27 | 0 |
| K872644 | INNOFLUOR VANCOMYCIN CALIBRATOR SET | Innotron of Oregon, Inc. | 1987-07-21 | 15 | 1 |
| K830101 | COLORIMETERS SERIES ONE 12 | Innotron of Oregon, Inc. | 1983-01-28 | 17 | 0 |
| K822942 | INNOTRON FLUORIMETER SERIES ONE-10 | Innotron of Oregon, Inc. | 1982-12-09 | 66 | 0 |
| K800601 | HYDRAGAMMA 16 | Innotron of Oregon, Inc. | 1980-04-10 | 24 | 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