Fujifilm Corporaton: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Fujifilm Corporaton” (first 2020, latest 2023), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 164 days. Since 2017 the median was 164 days, against 123 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.
Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 136 |
| 2021 | 2 | 134 |
| 2022 | 1 | 223 |
| 2023 | 2 | 159 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fujifilm Corporaton took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FDA | Enteroscope And Accessories | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- General and Plastic Surgery (2)
- Ear, Nose and Throat (1)
- Radiology (1)
Most recent Fujifilm Corporaton 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221551 | FUJIFILM Endoscope Model EI-740D/S | FDS | 2023-01-27 | 241 |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | FDA | 2023-01-11 | 77 |
| K220957 | FUJIFILM Endoscope Model EB-710P | EOQ | 2022-11-10 | 223 |
| K212950 | FUJIFILM Video Laparoscope EL-R740M30 | GCJ | 2021-12-02 | 77 |
| K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | GCJ | 2021-06-30 | 191 |
| K200973 | Synapse 3D Cardiac Tools | LLZ | 2020-08-27 | 136 |
Recalls
openFDA lists no recalls under a recalling firm named Fujifilm Corporaton.
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.
- Fujifilm Medical System U.S.A., Inc. (71 510(k)s)
- Fujifilm Corporation (70 510(k)s)
- Fujifilm Medical Systems U.S.A, Inc. (39 510(k)s)
- FUJIFILM Sonosite, Inc. (25 510(k)s)
- FUJIFILM Healthcare Americas Corporation (13 510(k)s)
- Fujifilm Healthcare Corporation (6 510(k)s)
- Fujifilm Irvine Scientific (5 510(k)s)
- Fujifilm New Development U.S.A., Inc. (3 510(k)s)
- Fujifilm Medwork GmbH (2 510(k)s)
- Fujifilm Meidcal Systems U.S.A.,Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fujifilm Corporaton?
FDA lists 6 510(k) clearances under the applicant name “Fujifilm Corporaton” (first 2020, latest 2023), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fujifilm Corporaton?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fujifilm Corporaton is 164 days. Since 2017: 164 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fujifilm Corporaton?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1); FDA (Enteroscope And Accessories, 1).
Next steps
- See all 6 Fujifilm Corporaton clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Fujifilm Corporaton'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.