Atlas FDA

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

Interacoustics A/S — Predicate Candidate Screening

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

133 daysmedian FDA review time
244 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200534VisualEyesInteracoustics A/S2020-08-121630
K200529OrionInteracoustics A/S2020-08-121630
K192652TRVInteracoustics A/S2020-05-272460
K191372LyraInteracoustics A/S2019-07-15540
K173567SeraInteracoustics A/S2018-02-14860
K163149VisualEyesInteracoustics A/S2017-04-261680
K162037Eclipse with VEMPInteracoustics A/S2017-03-232440
K152112VisualEyesInteracoustics A/S2015-12-291530
K151616AT235Interacoustics A/S2015-07-15300
K131681EYESEECAM VHITInteracoustics A/S2013-09-06880
K130795TITANInteracoustics A/S2013-06-20900
K121847TITANInteracoustics A/S2012-11-291570
K103760TITANInteracoustics A/S2011-05-051330
K102364NYDIAG 200Interacoustics A/S2010-12-231250
K072254VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEInteracoustics A/S2008-02-051750
K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)Interacoustics A/S2007-06-291080
K060883PILOT TEST OR DETECTIVE AUDIOMETERSInteracoustics A/S2006-06-23840

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