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

American Electromedics Corp. · Predicate Candidate Screening

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

91 daysmedian FDA review time

175 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
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
K983048	AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOM	American Electromedics Corp.	1998-11-17	77
K983046	AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRIN	American Electromedics Corp.	1998-11-17	77
K972221	K 15 AUDIOMETER	American Electromedics Corp.	1997-09-08	87
K970279	RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1	American Electromedics Corp.	1997-03-18	54
K955289	RACE CAR TYMPANOMETER	American Electromedics Corp.	1995-12-08	22
K951527	THE PILOT AUDIOMETER	American Electromedics Corp.	1995-05-03	30
K930164	THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S	American Electromedics Corp.	1993-04-23	100
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
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
K894260	AE-105D DIAGNOSTIC TYMPANOMETER	American Electromedics Corp.	1990-01-23	217
K883728	AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER	American Electromedics Corp.	1989-01-03	125
K881402	629V SPIROMETER, PULMONARY FUNCTION ANALYZER	American Electromedics Corp.	1988-09-26	175
K881760	AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER	American Electromedics Corp.	1988-06-10	46
K833045	CLINICAL TYMPANOMETER	American Electromedics Corp.	1983-12-08	93
K837029	ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE	American Electromedics Corp.	1983-03-22	102
K822745	THE SCREENING TYMPANOMETER	American Electromedics Corp.	1982-09-30	20

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