Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Konica Minolta Healthcare Americas, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
353 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | 2026-06-12 | 267 | 0 |
| K221853 | OTC DDR | Konica Minolta Healthcare Americas, Inc. | 2022-07-27 | 30 | 0 |
| K214030 | Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. | 2022-01-21 | 29 | 0 |
| K214012 | Straight Arm DDR | Konica Minolta Healthcare Americas, Inc. | 2022-01-12 | 21 | 0 |
| K203743 | EXA | Konica Minolta Healthcare Americas, Inc. | 2021-12-10 | 353 | 0 |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiog | Konica Minolta Healthcare Americas, Inc. | 2020-01-15 | 54 | 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