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

GMM — Predicate Candidate Screening

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

147 daysmedian FDA review time

162 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K981263	TOXOGEN	Instrumentation Laboratory CO	1998-08-06	121
K952818	ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII	Pyramid Biological Corp.	1995-11-20	153
K851977	HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT	Si Sero-Immuno Diagnostics, Inc.	1985-10-16	162
K851976	HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT	Si Sero-Immuno Diagnostics, Inc.	1985-10-16	162
K830870	POLYCHACO INDIRECT HEMAGGLUTINATION	Parasitic Disease Consultants	1983-08-12	147
K802452	TOXOTEST-MT EIKEN KIT	Syn-Kit, Inc.	1980-12-18	71
K790460	TXOCELL-IHA REAGENT SYSTEM	Calbiochem-Behring Corp.	1979-05-25	81
K771560	TOXHA TEST	Burroughs Wellcome Co.	1977-09-15	31

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