Canon, Inc.: FDA clearances and approvals
Canon, Inc. has 43 FDA 510(k) clearances (first 1994, latest 2026), across 8 product codes in 2 review panels. Median 510(k) review time: 26 days. Since 2017 its median was 27 days, against 72 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Canon, Inc. It files with the SEC as CANON INC (CAJFF, CAJPY).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 75 |
| 2014 | 1 | 210 |
| 2015 | 1 | 24 |
| 2016 | 1 | 224 |
| 2017 | 3 | 30 |
| 2018 | 0 | — |
| 2019 | 3 | 45 |
| 2020 | 3 | 87 |
| 2021 | 3 | 27 |
| 2022 | 7 | 23 |
| 2023 | 1 | 26 |
| 2024 | 2 | 148 |
| 2025 | 0 | — |
| 2026 | 1 | 265 |
Review time against the same product codes
Since 2017, Canon, Inc.'s cleared 510(k)s took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 72 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 27 | 27 |
| HKI | Camera, Ophthalmic, Ac-Powered | 7 | 7 |
| OWB | Interventional Fluoroscopic X-Ray System | 4 | 4 |
| HKO | Refractometer, Ophthalmic | 1 | 1 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| NFJ | System, Image Management, Ophthalmic | 1 | 1 |
| OBO | Tomography, Optical Coherence | 1 | 1 |
| PGY | Display, Diagnostic Radiology | 1 | 1 |
Review panels
- Radiology (32)
- Ophthalmic (11)
Most recent Canon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252503 | Intelligent NR | OWB | 2026-04-30 | 265 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | HKI | 2024-05-15 | 28 |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | OWB | 2024-04-26 | 269 |
| K230175 | Digital Radiography CXDI-CS01 | MQB | 2023-02-15 | 26 |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | MQB | 2022-10-17 | 26 |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | MQB | 2022-09-29 | 23 |
| K222661 | Digital Radiography CXDI-CS01 | MQB | 2022-09-27 | 25 |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | MQB | 2022-07-15 | 17 |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | MQB | 2022-06-14 | 11 |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | MQB | 2022-02-04 | 23 |
33 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-12-05.
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.
SEC filings
CANON INC (CAJFF, CAJPY): EDGAR filings, CIK 16988. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Canon, Inc. have?
Canon, Inc. has 43 FDA 510(k) clearances (first 1994, latest 2026), across 8 product codes in 2 review panels.
How long does FDA take to clear Canon, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Canon, Inc.'s cleared 510(k)s is 26 days. Since 2017: 27 days, versus 72 days for all cleared 510(k)s in the same product codes.
What devices does Canon, Inc. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 27); HKI (Camera, Ophthalmic, Ac-Powered, 7); OWB (Interventional Fluoroscopic X-Ray System, 4).
Has Canon, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Canon, Inc; the most recent began 2012-12-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 43 Canon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Canon, 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.