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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Tomey Corporation USA · Predicate Candidate Screening

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

84 daysmedian FDA review time
826 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971953CONFOSCANTomey Corporation USA1997-08-14780
K971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEMTomey Corporation USA1997-06-24480
K961805TOMEY DTL ELECTRODETomey Corporation USA1997-05-093640
K932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4Tomey Corporation USA1995-08-318260
K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USA1995-03-01840
K944910TOMEY EM-1000 SPECULAR MICROSCOPETomey Corporation USA1994-11-22480
K924760TOMEY PROTON TONOMETERTomey Corporation USA1993-04-051940
K921815TOMEY PE-300 PORTABLE ERGTomey Corporation USA1992-07-15910
K912112PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480Tomey Corporation USA1991-06-17350

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