Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sony Electronics, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
200 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191678 | IP Converter | Sony Electronics, Inc. | 2020-01-10 | 200 | 0 |
| K161122 | Sony IP Converter NU-IP40S | Sony Electronics, Inc. | 2016-06-08 | 48 | 0 |
| K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Son | Sony Electronics, Inc. | 2015-07-29 | 166 | 0 |
| K141454 | SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD | Sony Electronics, Inc. | 2014-06-26 | 24 | 0 |
| K141346 | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP | Sony Electronics, Inc. | 2014-06-26 | 35 | 0 |
| K120611 | SONY PVM-2551MD OLED MONITOR | Sony Electronics, Inc. | 2012-06-28 | 120 | 0 |
| K113203 | SONY LMD-2451MT LCD MONITOR | Sony Electronics, Inc. | 2012-02-24 | 116 | 0 |
| K083522 | SONY UP-DF750 DIGITAL FILM IMAGER | Sony Electronics, Inc. | 2009-01-09 | 44 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda