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

LZI · Predicate Candidate Screening

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

50 daysmedian FDA review time

123 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K043090	EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FI	Phonic Ear, Inc.	2004-12-23	45
K970974	WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER	Williams Sound, LLC	1997-05-02	46
K970340	AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER	Bellab	1997-03-26	56
K954748	POCKETALKER PRO	Williams Sound, LLC	1995-11-22	37
K952057	LISTENAIDER II	National Hearing Aid Dist., Inc.	1995-06-21	50
K934805	HEARIT	Je Liss & Co., Inc.	1994-02-07	123
K904755	ACOUSTIQ LISTENING DEVICE	Krueger Laboratories	1991-01-29	102

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