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

ETY — Predicate Candidate Screening

70 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time

157 days90th percentile

70clearances measured

K-number	Device	Applicant	Decided	Review days
K183201	Hearing Healthcare Pro	Db Diagnostic Systems, Inc.	2019-03-06	107
K171038	Hearing Healthcare Pro	Db Diagnostic Systems, Inc.	2017-08-02	118
K162210	touchTymp	Maico Diagnostics GmbH	2016-11-16	103
K161707	Madsen Zodiac	Gn Otometrics	2016-09-01	72
K151616	AT235	Interacoustics A/S	2015-07-15	30
K151509	GSI TympStar Pro Middle Ear Analyzer	Diagnostic Group, Dba Grason-Stadler	2015-06-25	21
K133013	INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE E	Inventis S.R.L.	2014-01-24	121
K121847	TITAN	Interacoustics A/S	2012-11-29	157
K083861	TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITA	Interacoustics AS	2009-04-09	106
K081841	AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER	Amplivox, Ltd.	2008-07-16	16
K070312	EARCHECK ACOUSTIC REFLECTOMETER	Innovia Medical, LLC	2007-03-02	29
K033645	OTOFLEX 100 TYE 1012	Gn Otometrics A/S	2004-03-31	132
K031978	AMPLAID A756 SCREENING ADMITTANCE METER	Amplaid	2003-07-21	25
K022728	AUDIOTRAVELLER, MODEL AA222	Interacoustics A/S, Assens	2002-10-11	56
K000097	GSI 2000 MIDDLE EAR ANALYZER	Grason-Stadler, Inc.	2000-04-12	90
K994254	INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER	International Distributors of Electronics For Medi	2000-03-14	88
K991562	PASCAL MEDICAL AB MENIETT 20	Pascal Medical AB	1999-12-28	238
K992370	AMPLAID A724 AND A728	Amplifon S.P.A.	1999-09-20	67
K990585	INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER	Idem (Int'L Dist. of Electronics For Medicine)	1999-05-17	83
K990652	INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER	Idem (Int'L Dist. of Electronics For Medicine)	1999-05-17	77
K983832	INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER	Idem (Int'L Dist. of Electronics For Medicine)	1999-01-25	87
K983049	AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH I	American Electromedics Corp.	1998-11-18	78
K983051	AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH	American Electromedics Corp.	1998-11-18	78
K983046	AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRIN	American Electromedics Corp.	1998-11-17	77
K974235	AMPLAID AM50	Amplifon S.P.A.	1998-02-10	90
K971859	EARCHECK	Mdi Instruments, Inc.	1997-08-18	90
K970685	EARCHECK PRO	Mdi Instruments, Inc.	1997-05-28	93
K955289	RACE CAR TYMPANOMETER	American Electromedics Corp.	1995-12-08	22
K953161	MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACH	Maico Hearing Instruments, Inc.	1995-07-24	17
K942008	INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER	Precision Acoustics Ind., Inc.	1994-08-24	121
K942007	INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26	Precision Acoustics Ind., Inc.	1994-08-24	121
K930164	THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S	American Electromedics Corp.	1993-04-23	100
K930165	AE-207D TYMPANOMETER	Amrex Electronics, Inc.	1993-04-23	100
K923072	HANDTYMP	Life-Tech Intl., Inc.	1993-03-18	266
K923073	AUTOMATIC TYMPANOMETER	Life-Tech Intl., Inc.	1993-02-19	239
K925585	GSI 38 AUTO TYMP	Lucas Grason-Stadler, Inc.	1993-02-02	90
K924933	AE-206 TYMPNOMWRWE(R) AUDIOMETER	American Electromedics Corp.	1993-01-21	113
K924934	AUTOMATIC IMPEDANCE METER AE-205	American Electromedics Corp.	1993-01-21	113
K910247	ZODIAC 901 MIDDLE-EAR ANALYZER	Madsen Electronics (Canada) , Ltd.	1991-06-19	148
K905704	MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER	Maico Hearing Instruments, Inc.	1991-04-30	130
K911095	GSI 37 AUTO TYMP	Lucas Grason-Stadler, Inc.	1991-03-29	16
K905213	MIDDLE EAR ANALYZER, MODEL AE-803	American Electromedics Corp.	1991-02-20	92
K905212	IMMITTANCE METER, MODEL AE-105D/S	American Electromedics Corp.	1991-02-19	91
K903066	AMPLAID 770 ADMITTANCE METER	Amplus Corp.	1990-10-24	104
K894260	AE-105D DIAGNOSTIC TYMPANOMETER	American Electromedics Corp.	1990-01-23	217
K895443	MODEL 210 IMPEDANCE SYSTEM	Virtual Corp.	1990-01-16	130
K895783	IMPEDANCE ANALYZER MODELS MD-2, MD-P	Singer Medical Products, Inc.	1989-12-05	132
K890864	HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.	Rastronics USA, Inc.	1989-06-21	120
K883293	STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT	Storz Instrument Co.	1989-06-09	309
K883728	AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER	American Electromedics Corp.	1989-01-03	125

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