Konica Minolta Healthcare Americas, Inc.: FDA clearances and approvals
Konica Minolta Healthcare Americas, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 42 days. Since 2017 its median was 42 days, against 104 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Konica Minolta Healthcare Americas, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 54 |
| 2021 | 1 | 353 |
| 2022 | 3 | 29 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 267 |
Review time against the same product codes
Since 2017, Konica Minolta Healthcare Americas, Inc.'s cleared 510(k)s took a median 42 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 3 | 3 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (6)
Most recent Konica Minolta Healthcare Americas, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252996 | Universal 1417PI | MQB | 2026-06-12 | 267 |
| K221853 | OTC DDR | KPR | 2022-07-27 | 30 |
| K214030 | Universal DR 1748 | MQB | 2022-01-21 | 29 |
| K214012 | Straight Arm DDR | KPR | 2022-01-12 | 21 |
| K203743 | EXA | LLZ | 2021-12-10 | 353 |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | KPR | 2020-01-15 | 54 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2021-12-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Konica Minolta Healthcare Americas, Inc. have?
Konica Minolta Healthcare Americas, Inc. has 6 FDA 510(k) clearances (first 2020, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear Konica Minolta Healthcare Americas, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Konica Minolta Healthcare Americas, Inc.'s cleared 510(k)s is 42 days. Since 2017: 42 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Konica Minolta Healthcare Americas, Inc. make?
Its most frequent FDA product codes are KPR (System, X-Ray, Stationary, 3); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); LLZ (System, Image Processing, Radiological, 1).
Has Konica Minolta Healthcare Americas, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Konica Minolta Healthcare Americas, Inc; the most recent began 2021-12-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Konica Minolta Healthcare Americas, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Konica Minolta Healthcare Americas, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.