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

DAS — Predicate Candidate Screening

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

73 daysmedian FDA review time

132 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K982023	PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT	Inova Diagnostics, Inc.	1998-09-04	87
K944876	HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT	Research Diagnostics, Inc.	1994-12-15	73
K943098	HUMAN IGG SUBCLASSES ELISA COMBI KIT	Research Diagnostics, Inc.	1994-09-07	71
K943205	HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)	Research Diagnostics, Inc.	1994-09-07	64
K895600	HUMAN (IGG) SUBCLASS (EIA) KIT	The Binding Site, Ltd.	1989-11-08	51
K790708	ANTISERUM TO HUMAN IG G FC FRAGMENTS	Kent Laboratories, Inc.	1979-08-22	132
K790715	ANTISERUM TO HUMAN FC	Kent Laboratories, Inc.	1979-08-16	126
K761156	AMINOGLYCOSIDE CONTROLS	Supelco, Inc.	1976-12-09	10

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