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

Owandy — Predicate Candidate Screening

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

186 daysmedian FDA review time

382 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K133271	OPTEO, VIDEOGRAPH HD	Owandy	2014-04-28	186	0
K130443	I-MAX TOUCH 3D	Owandy	2013-06-14	113	1
K093105	VISTEO	Owandy	2010-10-18	382	0
K083057	I-MAX TOUCH	Owandy	2009-06-02	231	0
K070505	KRYSTAL-X WIFI	Owandy	2007-04-05	43	0
K062403	IMAX CEPH DIGITAL X-RAY SENSOR	Owandy	2006-11-14	89	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