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

JQX — Predicate Candidate Screening

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

34 daysmedian FDA review time

95 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K962294	IMMAGE IMMUNOCHEMISTRY SYSTEM	Beckman Instruments, Inc.	1996-08-21	68	2
K922273	ARRAY(R) 360	Beckman Instruments, Inc.	1992-08-19	97	0
K885263	QMS(TM) - THEOPHYLLINE	Seradyn, Inc.	1989-03-28	95	0
K851253	TDX ANALYZER W/NEPHELOMETRY CAROUSEL	Abbott Laboratories	1985-04-30	33	0
K851234	A-JUST TURBIDITY METER	Abbott Laboratories	1985-04-29	34	0
K801362	ALBUMIN NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-07-21	42	0
K801089	J.T. BAKER NEPHELOMETER	J.T. Baker Chemical Co.	1980-05-28	20	0
K792045	BIOVATION NEPHELOMETER	Biovation, Inc.	1979-10-30	18	0
K790103	NEPHELOMETER, MIC-2000 LASER	Dynatech Corp.	1979-03-12	55	0
K781554	RAD-291	Organon, Inc.	1978-10-11	30	0
K781644	ANTIBIOTIC NEPHELOMETER	Biovation, Inc.	1978-10-03	8	0
K780251	NEPHELOMETER	Kallestad Laboratories, Inc.	1978-04-06	51	0
K772361	LASER IMMUNONEPHELOMETRIC ANALYZER	G.D. Searle and Co.	1978-01-30	34	0
K771446	TRANSPORTEO MODULE	Hyland Therapeutic Div., Travenol Laboratories	1977-08-10	9	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