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

Bernafon-Maico, Inc. · Predicate Candidate Screening

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

48 daysmedian FDA review time
84 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982723MAICO MA42Bernafon-Maico, Inc.1998-10-28840
K981142MAICO MA53Bernafon-Maico, Inc.1998-04-22230
K974069OPUS 2 - CANAL SERIES (ITC)Bernafon-Maico, Inc.1997-12-15480
K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)Bernafon-Maico, Inc.1997-12-15410
K974211OPUS 2 - FULL CONCHA SERIES - ITEBernafon-Maico, Inc.1997-12-15350
K973948DUALINE 100 BTEBernafon-Maico, Inc.1997-10-28120
K971158DUALINE 400 CICBernafon-Maico, Inc.1997-06-13770
K971080MAICO MA52Bernafon-Maico, Inc.1997-06-06730
K962275MAICO MA25 SERIES II WITH SPEECHBernafon-Maico, Inc.1996-09-05840

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