Atlas FDA

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

Intelligent Hearing Systems — Predicate Candidate Screening

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

90 daysmedian FDA review time
305 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163326SmartEPIntelligent Hearing Systems2017-09-293050
K090579SMARTSCREENER-PLUS2Intelligent Hearing Systems2009-07-071260
K073384SMART COUPLER, MODEL M015401Intelligent Hearing Systems2008-02-28870
K070608SMARTEP, MODEL M010000Intelligent Hearing Systems2007-07-181350
K063402WICK ELECTRODE, MODEL M019260Intelligent Hearing Systems2006-12-11320
K061443SMART USBLITE, MODEL M011120Intelligent Hearing Systems2006-06-23300
K052060OPTI-AMP DC-POWEREDIntelligent Hearing Systems2005-08-31330
K031051SMARTEP-ASSR, MODEL M811007Intelligent Hearing Systems2004-02-203240
K023859SMARTTROAEIntelligent Hearing Systems2003-01-08490
K964426SMARTOAEIntelligent Hearing Systems1997-02-03900
K925648SMART-SCREENER (AUDITORY)Intelligent Hearing Systems1993-05-111830
K914876OPTI-AMPIntelligent Hearing Systems1992-01-10730
K904926SMART-EPIntelligent Hearing Systems1991-08-022750

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