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

JHR · Predicate Candidate Screening

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

41 daysmedian FDA review time

132 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061970	ELECSYS IGE II IMMUNOASSAY	Roche Diagnostics	2006-08-31	50	0
K984326	ELECYS IGE ASSAY	Boehringer Mannheim Corp.	1999-02-08	67	0
K960067	IMMILITE TOTAL IGE	Diagnostic Products Corp.	1996-02-14	40	1
K931703	IMMULITE TOTAL IGE	Diagnostic Products Corp.	1993-08-16	132	2
K903000	TURBO-RAST SPECIFIC IGE ASSAY	Ventrex Laboratories, Inc.	1990-07-31	22	0
K901859	COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2	Diagnostic Products Corp.	1990-05-03	9	0
K882616	ALTERNATE PROCEDURE, PHARMACIA IGE EIA	Pharmacia, Inc.	1988-08-04	41	0
K873077	PHARMACIA IGE EIA	Pharmacia, Inc.	1987-10-20	76	0
K840103	RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN	Techniclone Intl.	1984-02-10	31	0

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