Atlas FDA

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

Zygo Industries, Inc. — Predicate Candidate Screening

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

205 daysmedian FDA review time
234 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K926029INFRA-LINKZygo Industries, Inc.1993-03-261150
K924030SCRIBEZygo Industries, Inc.1993-03-042050
K924014SECRETARYZygo Industries, Inc.1993-03-042050
K924015PARROTZygo Industries, Inc.1993-03-042050
K924013MACAWZygo Industries, Inc.1993-03-042050
K862766EPISON, ALERTING SYSTEM FOR EPILEPTICSZygo Industries, Inc.1987-03-132340

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