Konica Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Konica Corp.” (first 1992, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | 2 | 2 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
Review panels
- Radiology (5)
Most recent Konica Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992586 | KONICA LASER IMAGER, DRYPRO MODEL 722 | LMC | 1999-10-29 | 88 |
| K990359 | KONICA DIRECT DIGITIZER, MODEL DD-341 | MQB | 1999-08-17 | 193 |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | LMA | 1998-06-19 | 105 |
| K920769 | KONICA LI 10 AND 10A LASER IMAGER | LMC | 1992-05-06 | 90 |
| K920558 | KONICA DIRECT DIGITIZER KD-1000 | KPR | 1992-03-06 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Konica Corp..
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 Minolta, Inc. (25 510(k)s)
- Konica Medical Corp. (12 510(k)s)
- Konica Minolta Healthcare Americas, Inc. (6 510(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 Corp.?
FDA lists 5 510(k) clearances under the applicant name “Konica Corp.” (first 1992, latest 1999), 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Konica Corp. is 90 days.
Which FDA product codes appear under Konica Corp.?
The most frequent FDA product codes under this applicant name are LMC (Camera, Multi Format, Radiological, 2); KPR (System, X-Ray, Stationary, 1); LMA (Digitizer, Image, Radiological, 1).
Next steps
- See all 5 Konica Corp. clearances with predicates and recalls
- Run predicate analysis for product code LMC, Konica Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.