Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sony Medical Electronics Co. — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

37 daysmedian FDA review time
148 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980279SONY DXC-LS1 COLOR VIDEO CAMERASony Medical Electronics Co.1998-04-24880
K913886SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDERSony Medical Electronics Co.1992-01-241480
K904447SONY CINE VIDEO SYSTEM SME-3500Sony Medical Electronics Co.1990-10-17190
K902535SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEMSony Medical Electronics Co.1990-06-29210
K901153SONY VO-5800H VIDEOCASSETTE RECORDERSony Medical Electronics Co.1990-04-19370
K885042SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MDSony Medical Electronics Co.1988-12-22170
K884008SONY CINE VIDEO SYSTEM SME-3300Sony Medical Electronics Co.1988-11-30700
K882958SONY VIDEO PRINTERS, UP SERIESSony Medical Electronics Co.1988-08-04210

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