Atlas FDA

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

Vistech Consultants, Inc. · Predicate Candidate Screening

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

22 daysmedian FDA review time
81 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882634VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREVistech Consultants, Inc.1988-07-15180
K881059MCT 8000 (MULTI-VISION CONTRAST TESTER)Vistech Consultants, Inc.1988-04-04240
K881021VCTS 700S SYSTEMVistech Consultants, Inc.1988-04-01220
K881023VCTS 6500 SYSTEMVistech Consultants, Inc.1988-04-01220
K881022VCTS MARKETING PROGRAM SYSTEMVistech Consultants, Inc.1988-04-01220
K853481VISTECH VCTS GLARE TESTERVistech Consultants, Inc.1985-10-29700
K840255VISTECH VCTS 6000Vistech Consultants, Inc.1984-04-13810

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