Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GMK — Predicate Candidate Screening

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

28 daysmedian FDA review time
36 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K792694NEGATIVE CONTROL SERUMMeridian Diagnostics, Inc.1980-01-24280
K792692IMMUNODIFFUSION BAND INTENSIFYING FLUIDMeridian Diagnostics, Inc.1980-01-24280
K792679HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.1980-01-17210
K792718HISTOPLASMA CAPSULATUM, ANTISERUMMeridian Diagnostics, Inc.1980-01-17210
K791390ANTI-BLASTOMYCES SERUM #CF10027XImmuno-Mycologics, Inc.1979-08-16360
K791395ANTI-HISTOPLASMA SERUM #CF10025XImmuno-Mycologics, Inc.1979-08-16360
K791392ANTI-HISTOPLASMA SERUM #CF10026XImmuno-Mycologics, Inc.1979-08-16360
K760832ANTI-HISTOPLASMA CONTROL SERUM (YEAST)I M, Inc.1976-11-01190
K760831ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)I M, Inc.1976-11-01190

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