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

Gilford — Predicate Candidate Screening

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

34 daysmedian FDA review time

91 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K853465	GILFORD IMMUNOGLOBULIN G REAGENT	Gilford	1985-09-16	28
K853467	GILFORD IMMUNOGLOBULIN A REAGENT	Gilford	1985-09-16	28
K853469	GILFORD IMMUNOGLOBULIN M REAGENT	Gilford	1985-09-16	28
K853466	GILFORD C3 COMPLEMENT REAGENT	Gilford	1985-09-16	28
K853468	GILFORD C4 COMPLEMENT REAGENT	Gilford	1985-09-16	28
K851202	GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL	Gilford	1985-04-29	34
K842500	DATA MGMT. SYSTEM	Gilford	1984-08-16	51
K840120	ADVANTAGE	Gilford	1984-03-23	72
K833067	IMPACT 400 #1447X2	Gilford	1983-12-08	91
K812787	EIA RUBELLA	Gilford	1981-11-27	53

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