Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Konica Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
193 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992586 | KONICA LASER IMAGER, DRYPRO MODEL 722 | Konica Corp. | 1999-10-29 | 88 | 0 |
| K990359 | KONICA DIRECT DIGITIZER, MODEL DD-341 | Konica Corp. | 1999-08-17 | 193 | 0 |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | Konica Corp. | 1998-06-19 | 105 | 0 |
| K920769 | KONICA LI 10 AND 10A LASER IMAGER | Konica Corp. | 1992-05-06 | 90 | 0 |
| K920558 | KONICA DIRECT DIGITIZER KD-1000 | Konica Corp. | 1992-03-06 | 84 | 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