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

General Medical Merate S.P.A · Predicate Candidate Screening

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

92 daysmedian FDA review time

224 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K213081	CLISIS SYSTEMS, Discovery RF180	General Medical Merate S.P.A	2021-10-26	33	0
K173395	MECALL CLISIS SYSTEMS, Discovery RF180	General Medical Merate S.P.A	2018-05-21	203	0
K140380	OPERA SWING	General Medical Merate S.P.A	2014-09-26	224	0
K082243	PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS	General Medical Merate S.P.A	2008-11-07	92	3
K041605	PRECISION RXI ANALOG X-RAY SYSTEM	General Medical Merate S.P.A	2004-06-30	15	5
K881386	X-RAY GENERATING SYSTEM TF 1000	General Medical Merate S.P.A	1988-07-08	98	0
K827993	MTH C/A MOBILE C ARM	General Medical Merate S.P.A	1982-09-13	20	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