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

Eb Neuro S.P.A. — Predicate Candidate Screening

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

84 daysmedian FDA review time
198 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.2024-12-12840
K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.2024-09-04300
K150220STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 UEb Neuro S.P.A.2015-08-192010
K142064GALILEO NTEb Neuro S.P.A.2015-02-131980
K133517NEMUS 2 SYSTEMEb Neuro S.P.A.2014-02-261030
K121996BE PLUS LTM AMPLIFIER GWI AMPLIFIEREb Neuro S.P.A.2012-08-03250
K093728BE MICRO, TREAEb Neuro S.P.A.2010-04-291470
K073415NEMUS SYSTEM; NEMUS PC PERIPHERALEb Neuro S.P.A.2008-05-231710
K061996SANDMAN POCKETEb Neuro S.P.A.2006-10-03810
K053606BE PLUS / AURA-LTM64 AMPLIFIEREb Neuro S.P.A.2006-01-24280
K041198NIC36 AMPLIFIEREb Neuro S.P.A.2004-06-01250
K040113SANDMAN SD20 AMPLIFIEREb Neuro S.P.A.2004-02-18290
K003154MIZAR, BASIS BE, SANDMAN DIGITALEb Neuro S.P.A.2001-01-05870

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