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

Orion Corporation Soredex — Predicate Candidate Screening

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

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983267	DIGORA FOR WINDOWS 2.0	Orion Corporation Soredex	1998-12-30	104	0
K974877	CRANEX TOME CEPH, OR CRANEX TOME	Orion Corporation Soredex	1998-03-27	88	1
K934949	DIGORA	Orion Corporation Soredex	1994-02-10	115	0
K880982	ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY	Orion Corporation Soredex	1988-06-06	90	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