Atlas FDA

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

Vistek Corp. — Predicate Candidate Screening

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

64 daysmedian FDA review time
76 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K904681VLS 5300 300W XENON LIGHT SOURCEVistek Corp.1990-12-18640
K904682VISTEK ELECTRONIC CONTROLLERVistek Corp.1990-12-18640
K871034LCA 2000Vistek Corp.1987-04-10240
K860173VIS-2000 VIDEO SYSTEMVistek Corp.1986-02-07210
K843806VIS-1000 VIDEO SYSTEMVistek Corp.1984-12-12760

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