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

CZJ — Predicate Candidate Screening

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

70 daysmedian FDA review time

189 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K092450	HUMAN IGD KIT FOR USE ON SPAPLUS	The Binding Site	2009-12-28	140
K051299	IGD DIAGNOSTIC TEST KITS	The Binding Site, Ltd.	2005-11-23	189
K002561	SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT	The Binding Site, Ltd.	2000-10-26	70
K913671	HUMAN IGD IMMUNOLOGICAL NL TEST KIT	The Binding Site, Ltd.	1991-12-02	105
K883001	QM300 CALIBRATOR D PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1988-09-22	66
K872834	TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410	Helena Laboratories	1987-08-12	26
K831956	DETERM. SIZE 72 RADIAL-HUMAN IGD	Kent Laboratories, Inc.	1983-07-18	31
K772327	LAS-R HUMAN IGD TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-02-28	69

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