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

Palodex Group OY — Predicate Candidate Screening

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

128 daysmedian FDA review time

268 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241249	Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP	Palodex Group OY	2024-09-12	132	0
K230505	Orthopantomograph™ OP 3D LX	Palodex Group OY	2023-06-09	105	0
K180947	Orthopantomograph OP 3D	Palodex Group OY	2018-06-07	57	0
K173646	FS Ergo	Palodex Group OY	2017-12-19	22	0
K163423	Orthopantomograph OP300	Palodex Group OY	2017-08-31	268	1
K162799	Cliniview	Palodex Group OY	2017-04-25	202	0
K170813	ORTHOPANTOMOGRAPH OP 3D	Palodex Group OY	2017-04-07	21	0
K133544	OP300	Palodex Group OY	2014-03-26	128	0
K130297	SCANORA 3DX	Palodex Group OY	2013-05-29	112	0
K122018	OP300	Palodex Group OY	2012-12-10	153	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