Atlas FDA

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

GMI — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

28 daysmedian FDA review time
103 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894617OLYMPUS PK-TP SYSTEM REACTIVE CONTROLSchiff & Co.1989-10-311030
K812190COCCIDIOIDES IMMUNODIFFUSION SYSTEMAmerican Scientific Products1981-08-31280
K812185FUNGAL IMMUNODIFFUSION SYSTEMAmerican Scientific Products1981-08-25220
K802129IMMUNODIFFUSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.1980-09-26530
K792716CANDIDA ALBICANS, ANTIGENMeridian Diagnostics, Inc.1980-01-24280
K792713CANDIDA ALBICANS, ANTISERUMMeridian Diagnostics, Inc.1980-01-23270
K792689COCCIDIOIDES IMMITIS, ANTIGENMeridian Diagnostics, Inc.1980-01-17210
K792682COCCIDIOIDES IMMITIS, ANTIGENMeridian Diagnostics, Inc.1980-01-17210
K791389COCCIDIOIDES ANTIGEN #CF10023XImmuno-Mycologics, Inc.1979-08-16360
K791383CANDIDA IMMUNODIFFUSION KIT #CA1001Immuno-Mycologics, Inc.1979-08-16360
K770527CANDIDA IMMUNODIFFUSION KITI M, Inc.1978-03-173640

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