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

DBA — Predicate Candidate Screening

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

59 daysmedian FDA review time

209 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141100	OPTILITE C1 INACTIVATOR KIT	The Binding Site Group , Ltd.	2014-07-18	80	0
K122304	HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS	The Binding Site Group , Ltd.	2013-04-15	257	0
K072965	DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON	Dade Behring, Inc.	2007-12-21	60	0
K011780	K-ASSAY C1-INA	Kamiya Biomedical Co.	2001-07-25	48	0
K003747	C1-INHIBITOR MICROTITER ASSAY DEVICE	Baxter Healthcare Corp	2001-03-19	105	0
K965024	N-ASSAY TIA C1-INACTIVATOR TEST KIT	Crestat Diagnostics, Inc.	1997-07-14	209	0
K960257	N ANTISERUM TO C1 INHIBITOR	Behring Diagnostics, Inc.	1996-08-01	196	0
K951967	HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNO	Kent Laboratories, Inc.	1995-05-30	33	0
K915431	COMPLEMENT C1 INACTIVATOR KIT	The Binding Site, Ltd.	1992-01-17	46	0
K872426	CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY	Cytotech, Inc.	1987-07-23	31	1
K821898	ORTHO CLASSICAL PATHWAY COMPL. TEST	Ortho Diagnostic Systems, Inc.	1982-07-16	18	0
K781017	ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)	Icl Scientific	1978-08-14	59	0
K780335	LAS-R HUMAN C1 ESTERASE INHIBITOR TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-03-22	22	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