Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EWO — Predicate Candidate Screening
235 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
216 days90th percentile
235clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | 2024-06-21 | 178 | 0 |
| K240430 | Otoport Pro | Otodynamics, Ltd. | 2024-03-15 | 30 | 0 |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | 2023-10-27 | 150 | 0 |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, S | Path Medical GmbH | 2022-06-22 | 257 | 4 |
| K191372 | Lyra | Interacoustics A/S | 2019-07-15 | 54 | 0 |
| K180287 | GSI Corti | Grason-Stadler, Inc. | 2018-05-11 | 99 | 0 |
| K173567 | Sera | Interacoustics A/S | 2018-02-14 | 86 | 0 |
| K172403 | GSI Novus | Grason-Stadler, Inc. | 2017-10-20 | 72 | 0 |
| K171506 | Easyscreen | Maico Diagnostics GmbH | 2017-08-29 | 98 | 0 |
| K151025 | iHearTest | Ihear Medical, Inc. | 2015-12-29 | 257 | 0 |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | 2015-03-26 | 29 | 0 |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | 2015-03-12 | 276 | 0 |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE | Otodynamics, Ltd. | 2015-02-23 | 89 | 0 |
| K133012 | SENTIERO | Path Medical GmbH | 2014-06-09 | 257 | 4 |
| K130795 | TITAN | Interacoustics A/S | 2013-06-20 | 90 | 0 |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | 2013-03-28 | 125 | 0 |
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | 2012-11-01 | 77 | 0 |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | 2012-07-26 | 66 | 0 |
| K112992 | EARLOGIC OAE TESTER | Earlogic Corporation | 2012-04-20 | 197 | 0 |
| K112247 | A BAER WITH ABAER I/O FUNCTION | Natus Medical Incorporated | 2012-04-02 | 242 | 0 |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O | Natus Medical Incorporated | 2011-12-28 | 201 | 0 |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2011-12-16 | 87 | 0 |
| K103298 | ACAM 5 AUDIOMETER SYSTEM | Acousticon GmbH | 2011-04-08 | 151 | 0 |
| K092089 | CLARUJUST | Audigence, Inc. | 2010-03-10 | 244 | 0 |
| K092244 | MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS | Diagnostic Group, LLC | 2010-03-01 | 216 | 0 |
| K092111 | ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIA | Entomed AB | 2009-10-02 | 80 | 0 |
| K090406 | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE | Interacoustics AS | 2009-07-22 | 155 | 0 |
| K081234 | GN OTOMETRICS INSERT EARPHONES | Gn Otometrics | 2008-07-14 | 74 | 0 |
| K072033 | OTODYNAMICS OTOPORT | Otodynamics, Ltd. | 2007-11-13 | 112 | 0 |
| K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | 2007-06-07 | 69 | 0 |
| K063452 | MA 55 MAESTRO | Maico Diagnostics (Diagnostic Group, LLC) | 2007-03-29 | 134 | 0 |
| K070118 | OTOGRAM, CA3350 | Tympany, Inc. | 2007-03-07 | 54 | 0 |
| K063338 | HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER | Mimosa Acoustics, Inc. | 2007-01-04 | 59 | 0 |
| K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS | Bio-Logic Systems Corp. | 2006-09-15 | 86 | 0 |
| K060883 | PILOT TEST OR DETECTIVE AUDIOMETERS | Interacoustics A/S | 2006-06-23 | 84 | 0 |
| K060885 | MODEL MI 44 TYMPANOMETER | Maico-Diagnostics | 2006-06-05 | 66 | 0 |
| K060539 | DPOAE20 , ECLIPSE | Interacoustics A/S, Assens | 2006-05-30 | 90 | 0 |
| K053216 | HEARID WIDEBAND MIDDLE EAR POWER ANALYZER | Mimosa Acoustics, Inc. | 2006-02-10 | 85 | 0 |
| K052562 | ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF | Interacoustics AS | 2005-12-23 | 95 | 0 |
| K043219 | AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION O | Interacoustics AS | 2005-02-04 | 74 | 0 |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | Vivosonic, Inc. | 2003-10-27 | 27 | 0 |
| K031713 | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE | Viasys Healthcare, Inc. | 2003-08-12 | 71 | 0 |
| K031986 | ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS | Ics Medical | 2003-07-24 | 27 | 0 |
| K031352 | BIO-LOGIC INSERT EARPHONES | Bio-Logic Systems Corp. | 2003-07-16 | 78 | 0 |
| K030016 | TEOAE25 | Interacoustics A/S, Assens | 2003-03-28 | 85 | 0 |
| K024205 | AUDIOSCREENER OAE+ABR | Everest Biomedical Instruments Co. | 2003-03-07 | 77 | 0 |
| K023859 | SMARTTROAE | Intelligent Hearing Systems | 2003-01-08 | 49 | 0 |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | Bio-Logic Systems Corp. | 2002-06-27 | 24 | 0 |
| K011135 | GSI AUDERA | Nicolet Biomedical | 2001-07-26 | 104 | 1 |
| K003364 | VIVO 200 DPS VIVOSCAN | Vivosonic, Inc. | 2001-07-18 | 264 | 0 |
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