Konica Minolta, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Konica Minolta, Inc.” (first 2014, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 77 days, against 104 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 3 | 102 |
| 2015 | 3 | 29 |
| 2016 | 2 | 56 |
| 2017 | 2 | 52 |
| 2018 | 4 | 55 |
| 2019 | 1 | 58 |
| 2020 | 0 | — |
| 2021 | 3 | 115 |
| 2022 | 3 | 48 |
| 2023 | 1 | 25 |
| 2024 | 2 | 158 |
| 2025 | 1 | 104 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Konica Minolta, Inc. took a median 77 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 12 | 12 |
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
Review panels
- Radiology (25)
Most recent Konica Minolta, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250665 | SKR 3000 | MQB | 2025-06-17 | 104 |
| K241319 | SKR 3000 | MQB | 2024-11-21 | 195 |
| K240281 | Bone Suppression Software | LLZ | 2024-05-31 | 120 |
| K230906 | Konicaminolta DI-X1 | LLZ | 2023-04-25 | 25 |
| K223267 | SKR 3000 | MQB | 2022-11-17 | 24 |
| K220993 | Ultrasound System SONIMAGE MX1 | IYN | 2022-06-23 | 80 |
| K213908 | SKR 3000 | MQB | 2022-01-31 | 48 |
| K212685 | KONICAMINOLTA DI-X1 | LLZ | 2021-09-13 | 20 |
| K210619 | SKR 3000 | MQB | 2021-08-24 | 176 |
| K210066 | ImagePilot | LLZ | 2021-05-06 | 115 |
15 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-04-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Konica Minolta Medical & Graphic, Inc. (27 510(k)s)
- Konica Medical Corp. (12 510(k)s)
- Konica Minolta Healthcare Americas, Inc. (6 510(k)s)
- Konica Corp. (5 510(k)s)
- Konica Minolta Sensing, Inc. (3 510(k)s)
- Konica Medical and Graphic Corporation (1 510(k)s)
- Konica Minolta Technoproduct Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Konica Minolta, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Konica Minolta, Inc.” (first 2014, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Konica Minolta, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Konica Minolta, Inc. is 58 days. Since 2017: 77 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Konica Minolta, Inc.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 12); LLZ (System, Image Processing, Radiological, 6); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4).
Next steps
- See all 25 Konica Minolta, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Konica Minolta, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.