Sony Electronics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sony Electronics, Inc.” (first 2009, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 | 2 | 118 |
| 2013 | 0 | — |
| 2014 | 2 | 30 |
| 2015 | 1 | 166 |
| 2016 | 1 | 48 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 200 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sony Electronics, Inc. took a median 200 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| LMC | Camera, Multi Format, Radiological | 3 | 3 |
Review panels
Most recent Sony Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191678 | IP Converter | GCJ | 2020-01-10 | 200 |
| K161122 | Sony IP Converter NU-IP40S | GCJ | 2016-06-08 | 48 |
| K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor | GCJ | 2015-07-29 | 166 |
| K141454 | SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD | LMC | 2014-06-26 | 24 |
| K141346 | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD | LMC | 2014-06-26 | 35 |
| K120611 | SONY PVM-2551MD OLED MONITOR | GCJ | 2012-06-28 | 120 |
| K113203 | SONY LMD-2451MT LCD MONITOR | GCJ | 2012-02-24 | 116 |
| K083522 | SONY UP-DF750 DIGITAL FILM IMAGER | LMC | 2009-01-09 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Sony Electronics, Inc..
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 Medical Electronics Co. (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 Electronics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Sony Electronics, Inc.” (first 2009, latest 2020), across 2 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 Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sony Electronics, Inc. is 82 days.
Which FDA product codes appear under Sony Electronics, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); LMC (Camera, Multi Format, Radiological, 3).
Next steps
- See all 8 Sony Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Sony Electronics, 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.