Atlas FDA

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

Tonica Elektronik A/S · Predicate Candidate Screening

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

122 daysmedian FDA review time
286 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S2026-05-221200
K251125MagVenture TMS Therapy SystemTonica Elektronik A/S2025-08-111220
K251119MagVenture TMS Therapy SystemTonica Elektronik A/S2025-08-081190
K252032T65 (9016E061-)Tonica Elektronik A/S2025-07-30300
K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOptiTonica Elektronik A/S2023-08-252340
K221544MagVenture TMS Atlas Neuro Navigation SystemTonica Elektronik A/S2023-03-172940
K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMTonica Elektronik A/S2020-08-092860
K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S2018-08-142650
K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S2017-10-05300
K171967MagVita TMS Therapy SystemTonica Elektronik A/S2017-07-25250
K171481MagVita TMS Therapy SystemTonica Elektronik A/S2017-06-16280
K170114MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S2017-05-011090
K162873MEP MonitorTonica Elektronik A/S2017-03-311690
K160280MagPro R20Tonica Elektronik A/S2016-05-161040
K150641MagVita TMS Therapy SystemTonica Elektronik A/S2015-07-311420
K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTIONTonica Elektronik A/S2010-03-262690
K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65Tonica Elektronik A/S2007-07-27240
K061645MAGPRO, MODEL R30Tonica Elektronik A/S2006-10-311410

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