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

Raysearch Laboratories AB — Predicate Candidate Screening

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

77 daysmedian FDA review time

111 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141860	RAYSTATION	Raysearch Laboratories AB	2014-10-23	105	5
K140187	RAY STATION	Raysearch Laboratories AB	2014-05-15	111	1
K130617	RAYSTATION	Raysearch Laboratories AB	2013-05-10	64	6
K120387	RAYSTATION	Raysearch Laboratories AB	2012-04-06	59	6
K100552	RAYSTATION VERSION 1.0	Raysearch Laboratories AB	2010-03-12	14	4
K083264	RAYAUTOPLAN 1.0	Raysearch Laboratories AB	2009-01-22	78	2
K082221	RAYDOSE	Raysearch Laboratories AB	2008-10-22	77	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