Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GWJ — Predicate Candidate Screening
76 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
235 days90th percentile
76clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024-12-19 | 85 | 0 |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 | 115 | 0 |
| K220139 | QScreen | Path Medical GmbH | 2022-08-03 | 197 | 0 |
| K211147 | ALGO 7i | Path Medical GmbH | 2021-10-14 | 178 | 0 |
| K193033 | GSI Audera Pro | Grason Stadler | 2020-04-24 | 176 | 0 |
| K163326 | SmartEP | Intelligent Hearing Systems | 2017-09-29 | 305 | 0 |
| K162037 | Eclipse with VEMP | Interacoustics A/S | 2017-03-23 | 244 | 0 |
| K143670 | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | 2015-10-23 | 303 | 0 |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, E | Natus Medical Incorporated | 2014-08-22 | 81 | 0 |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Gn Otometrics | 2014-02-27 | 160 | 0 |
| K131141 | EARPROBE | Path Medical GmbH | 2013-06-27 | 65 | 0 |
| K123701 | HEARLAB ACA | Frye Electronics, Inc. | 2013-04-05 | 123 | 0 |
| K122067 | TYPE 1077 ACCUSCREEN | Gn Otometrics | 2012-09-27 | 73 | 0 |
| K111555 | CIRCUMAURAL ADHESIVE REPLACEMENT | R & D Medical Products, Inc. | 2011-07-25 | 52 | 0 |
| K103760 | TITAN | Interacoustics A/S | 2011-05-05 | 133 | 0 |
| K100661 | EARPROBE | Path Medical GmbH | 2010-07-01 | 115 | 1 |
| K092373 | ICS CHARTR EP 200 | Gn Otometrics | 2009-09-03 | 29 | 0 |
| K090579 | SMARTSCREENER-PLUS2 | Intelligent Hearing Systems | 2009-07-07 | 126 | 0 |
| K083399 | ICS CHARTR EP 200 | Gn Otometrics A/S | 2009-02-20 | 95 | 0 |
| K082035 | MAICO MB 11 WITH BERAPHONE PROBE | Maico Diagnostics | 2009-01-29 | 196 | 0 |
| K080060 | VIVOSONIC NEUROSCREEN | Vivosonic, Inc. | 2008-04-04 | 86 | 0 |
| K073384 | SMART COUPLER, MODEL M015401 | Intelligent Hearing Systems | 2008-02-28 | 87 | 0 |
| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | 2008-02-05 | 41 | 0 |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2008-01-25 | 30 | 0 |
| K070608 | SMARTEP, MODEL M010000 | Intelligent Hearing Systems | 2007-07-18 | 135 | 0 |
| K070696 | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) | Interacoustics A/S | 2007-06-29 | 108 | 0 |
| K061443 | SMART USBLITE, MODEL M011120 | Intelligent Hearing Systems | 2006-06-23 | 30 | 0 |
| K043396 | INTEGRITY, MODEL V500 | Vivosonic, Inc. | 2005-01-24 | 45 | 0 |
| K031051 | SMARTEP-ASSR, MODEL M811007 | Intelligent Hearing Systems | 2004-02-20 | 324 | 0 |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | Bio-Logic Systems Corp. | 2003-05-09 | 46 | 0 |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | Bio-Logic Systems Corp. | 2003-04-28 | 28 | 0 |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2003-04-09 | 26 | 1 |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | 2002-07-01 | 21 | 0 |
| K013977 | ECHO-SCREEN T, TA, TD, TDA, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002-06-14 | 193 | 0 |
| K021215 | BIO-LOGIC ABAER CUB | Bio-Logic Systems Corp. | 2002-05-15 | 28 | 0 |
| K011842 | SABRE COMPAC | Sle Limited | 2002-01-08 | 210 | 0 |
| K012415 | AURIS AEP | Synapsys, Inc. | 2001-12-18 | 141 | 0 |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2001-10-16 | 27 | 1 |
| K011746 | MB 11 | Maico Diagnostic GmbH | 2001-08-24 | 79 | 0 |
| K002985 | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS | Ics Medical Corp. | 2000-12-13 | 79 | 0 |
| K994149 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGA | Bio-Logic Systems Corp. | 1999-12-27 | 19 | 0 |
| K993177 | SABRE | Sle Limited | 1999-11-16 | 85 | 0 |
| K991853 | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT | Idem (Int'L Dist. of Electronics For Medicine) | 1999-10-25 | 146 | 0 |
| K992807 | BIO-LOGIC EVOKED POTENTIAL FOR ABAER I | Bio-Logic Systems Corp. | 1999-09-14 | 25 | 0 |
| K972157 | EXCEL AV STIM 1000 | Excel Tech. , Ltd. | 1998-01-30 | 235 | 0 |
| K960097 | CHARTR EP | Ics Medical Corp. | 1997-02-21 | 407 | 0 |
| K953732 | TECA PREMIERE | Medelec , Ltd. | 1995-10-19 | 80 | 0 |
| K952080 | CLARITY SYSTEM II | Sonamed Corp. | 1995-09-19 | 139 | 1 |
| K936039 | ALGO-2 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 1995-01-05 | 381 | 1 |
| K925648 | SMART-SCREENER (AUDITORY) | Intelligent Hearing Systems | 1993-05-11 | 183 | 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