Sony Medical Electronics Co.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sony Medical Electronics Co.” (first 1988, latest 1998), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 3 | 3 |
| IZI | System, X-Ray, Angiographic | 2 | 2 |
| KQM | Camera, Surgical And Accessories | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Sony Medical Electronics Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980279 | SONY DXC-LS1 COLOR VIDEO CAMERA | GCJ | 1998-04-24 | 88 |
| K913886 | SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER | JAA | 1992-01-24 | 148 |
| K904447 | SONY CINE VIDEO SYSTEM SME-3500 | IZI | 1990-10-17 | 19 |
| K902535 | SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM | JAA | 1990-06-29 | 21 |
| K901153 | SONY VO-5800H VIDEOCASSETTE RECORDER | JAA | 1990-04-19 | 37 |
| K885042 | SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD | KQM | 1988-12-22 | 17 |
| K884008 | SONY CINE VIDEO SYSTEM SME-3300 | IZI | 1988-11-30 | 70 |
| K882958 | SONY VIDEO PRINTERS, UP SERIES | KQM | 1988-08-04 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Sony Medical Electronics Co..
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.
- Sony Electronics, Inc. (8 510(k)s)
- Sony Medical Systems (6 510(k)s)
- Sony Corp. of America (2 510(k)s)
- Sony Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sony Medical Electronics Co.?
FDA lists 8 510(k) clearances under the applicant name “Sony Medical Electronics Co.” (first 1988, latest 1998), across 4 product codes in 2 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 Sony Medical Electronics Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sony Medical Electronics Co. is 29 days.
Which FDA product codes appear under Sony Medical Electronics Co.?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 3); IZI (System, X-Ray, Angiographic, 2); KQM (Camera, Surgical And Accessories, 2).
Next steps
- See all 8 Sony Medical Electronics Co. clearances with predicates and recalls
- Run predicate analysis for product code JAA, Sony Medical Electronics Co.'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.