Atlas FDA

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

Ibramed Equipamentos Médicos — Predicate Candidate Screening

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

265 daysmedian FDA review time
393 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242859VEGAIbramed Equipamentos Médicos2025-09-193640
K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos2021-05-11740
K131926THERMOPULSEIbramed Equipamentos Medicos2014-07-243930
K131917NEURODYN COMPACT, NEURODYN IIIbramed Equipamentos Medicos2014-04-293070
K131309SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZIbramed Equipamentos Medicos2014-01-272650
K131629NEURODYN MULTIWAVE, AUSSIE SPORTIbramed Equipamentos Medicos2013-11-261750
K121369NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMIbramed Equipamentos Medicos2012-12-192260

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