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

Vysis — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time

502 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
DEN040010	VYSIS AUTOVYSION SYSTEM	Vysis	2004-12-13	61	0
K033982	MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TE	Vysis	2004-01-22	30	0
K013785	UROVYSION BLADDER CANCER RECURRENCE KIT	Vysis	2002-02-08	86	1
K011031	VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT	Vysis	2001-08-03	120	1
K010288	ANEUVYSION MULITICOLOR DNA PROBE KIT	Vysis	2001-04-13	72	0
K972200	ANEUVYSION	Vysis	1997-10-20	132	0
K954214	CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT	Vysis	1997-01-21	502	0
K962873	CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION	Vysis	1997-01-13	174	0
K953591	CEP 8 SPECTRUMORANGE DNA PROBE KIT	Vysis	1996-11-29	486	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