Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Konica Minolta, Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
134 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250665 | SKR 3000 | Konica Minolta, Inc. | 2025-06-17 | 104 | 0 |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024-11-21 | 195 | 0 |
| K240281 | Bone Suppression Software | Konica Minolta, Inc. | 2024-05-31 | 120 | 0 |
| K230906 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2023-04-25 | 25 | 0 |
| K223267 | SKR 3000 | Konica Minolta, Inc. | 2022-11-17 | 24 | 0 |
| K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2022-06-23 | 80 | 0 |
| K213908 | SKR 3000 | Konica Minolta, Inc. | 2022-01-31 | 48 | 0 |
| K212685 | KONICAMINOLTA DI-X1 | Konica Minolta, Inc. | 2021-09-13 | 20 | 0 |
| K210619 | SKR 3000 | Konica Minolta, Inc. | 2021-08-24 | 176 | 0 |
| K210066 | ImagePilot | Konica Minolta, Inc. | 2021-05-06 | 115 | 0 |
| K191645 | SKR 4000 | Konica Minolta, Inc. | 2019-08-16 | 58 | 0 |
| K182688 | SKR 3000 | Konica Minolta, Inc. | 2018-12-18 | 83 | 0 |
| K182431 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2018-11-26 | 81 | 0 |
| K182153 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2018-09-06 | 29 | 0 |
| K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2018-02-08 | 28 | 0 |
| K172793 | SKR 3000 | Konica Minolta, Inc. | 2017-10-12 | 27 | 0 |
| K171716 | SKR 3000 | Konica Minolta, Inc. | 2017-08-25 | 77 | 0 |
| K162065 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2016-10-19 | 85 | 0 |
| K162504 | SKR 3000 | Konica Minolta, Inc. | 2016-10-03 | 26 | 0 |
| K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | Konica Minolta, Inc. | 2015-10-08 | 29 | 0 |
| K151465 | AeroDR SYSTEM 2 | Konica Minolta, Inc. | 2015-06-29 | 28 | 0 |
| K151060 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2015-06-05 | 46 | 0 |
| K142197 | ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX P | Konica Minolta, Inc. | 2014-11-21 | 102 | 0 |
| K141271 | AERODR SYSTEM 2 | Konica Minolta, Inc. | 2014-09-26 | 134 | 0 |
| K133730 | CO PILOT/REGIUS UNITEA | Konica Minolta, Inc. | 2014-01-31 | 56 | 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