Atlas FDA

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

Kay Elemetrics Corp. — Predicate Candidate Screening

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

80 daysmedian FDA review time
230 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991738DIGITAL VIDEO RECORDING SYSTEMKay Elemetrics Corp.1999-08-13840
K990240ELECTROGLOTTOGRAPHKay Elemetrics Corp.1999-03-11450
K9547987100 SWALLOWING WORKSTATIONKay Elemetrics Corp.1996-06-042300
K9212859105 RIGID TELESCOPIC ENDOSCOPEKay Elemetrics Corp.1992-05-28720
K921184RLS 9100 RHINO-LARYNGEAL STROBOSCOPEKay Elemetrics Corp.1992-05-28800

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