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

JSX — Predicate Candidate Screening

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

62 daysmedian FDA review time

198 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K960759	GONOPOX TEST KIT	Medtex Laboratories, Inc.	1996-09-18	205
K923566	NIZYME TEST KIT	Remel Co.	1992-11-02	108
K913456	VISI-NEISSERIA	Kev Connecticut Diagnostics, Inc.	1991-10-11	67
K880511	XACT NEISSERIA	Austin Biological Laboratories	1988-08-25	198
K881501	MODIFIED IDS RAPID NH SYSTEM	Innovative Diagnostic Systems, Inc.	1988-05-18	37
K870117	NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST	Pro-Lab, Inc.	1987-03-20	67
K853544	QUAD FERM +	Analytical Products, Inc.	1985-09-05	10
K852998	NEISSERIA - KWIK PLUS	Micro-Bio-Logics	1985-07-23	8
K852582	GONI-KIT	Culture Kits, Inc.	1985-07-12	24
K833307	PHADEBACK G.C. POSITIVE CONTROLS	Pharmacia, Inc.	1983-12-27	95
K833180	GONOCHEK-II	E-Y Laboratories, Inc.	1983-11-14	56
K830364	NEISSERIA IDENTIFICATION DISCS	Oxoid U.S.A., Inc.	1983-03-08	32
K812048	IDS RAPIDS NH SYSTEMS	Carr-Scarborough Microbiologicals, Inc.	1981-08-18	29
K811412	NEISSERIA-KWIK	Windsor Laboratories, Inc.	1981-06-16	28
K782013	GONO-CELL	Abbott Laboratories	1979-04-23	139
K781108	MICROCULT-GC CULTURE TEST	Miles Laboratories, Inc.	1978-08-31	62

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