Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JXB — Predicate Candidate Screening

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

69 daysmedian FDA review time

184 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K080719	YEAST TRAFFIC LIGHT PNA FISH	Advandx, Inc.	2008-09-12	183	0
K062461	C. ALBICANS PNA FISH	Advandx, Inc.	2006-10-25	63	0
K993554	YEASTEST	Diagnostic Markers, Inc.	2000-02-10	113	0
K943621	RAPID YEAST PLUS SYSTEM	Innovative Diagnostic Systems, Inc.	1995-01-27	184	2
K935124	BACTICARD CANDIDA	Remel Co.	1994-02-25	120	0
K900112	MICRORING YT	Medical Wire & Equipment Co.	1990-07-31	203	0
K881925	VITEK YEAST BIOCHEMICAL CARD	Vitek Systems, Inc.	1988-06-16	38	0
K860575	YEAST IDENTIFICATION PANEL	American Micro Scan	1986-05-13	84	0
K830286	YEAST IDENT	Analytical Products, Inc.	1983-04-05	68	0
K802309	MS-2 IDENTIFICATION SYSTEM	Abbott Laboratories	1980-12-01	69	0
K800803	NITRATE SWAB-RAPID TEST	Remel Co.	1980-07-08	89	0
K800908	CAPIK-CANDIDA ALBICANS IDENT. KIT.	Immuno-Mycologics, Inc.	1980-06-02	42	0
K792231	AMS YEAST BIOCHEMICAL CARD	Vitek Systems, Inc.	1979-12-19	44	0
K790991	YEAST-PALETTE TM	Micro-Palettes, Inc.	1979-06-22	24	0
K790671	DERMATOPHYTIN O	Diagnostica, Inc.	1979-05-31	55	0
K771008	API 20C	Analytical Products, Inc.	1977-08-03	61	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