Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Konica Minolta Sensing, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053419 | KONICA MINOLTA PULSOX-300, 300I | Konica Minolta Sensing, Inc. | 2006-05-11 | 154 | 0 |
| K021469 | MINOLTA PULSOX-2 | Konica Minolta Sensing, Inc. | 2003-02-12 | 281 | 0 |
| K010413 | MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI | Konica Minolta Sensing, Inc. | 2001-08-02 | 171 | 2 |
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