Atlas FDA

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

Hearing Tech, Inc. — Predicate Candidate Screening

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

53 daysmedian FDA review time
85 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K941587HEARING TECHHearing Tech, Inc.1994-06-24850
K924712ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEMHearing Tech, Inc.1992-12-08810
K905680543 SERIES BTEHearing Tech, Inc.1991-03-08790
K903295ESCORT ITCHearing Tech, Inc.1990-09-05420
K903023HERITAGE III (HTC) ITC TYPE HEARING AIDHearing Tech, Inc.1990-07-27170
K870723HEARTECH HFX, HEARING AIDHearing Tech, Inc.1987-03-20240
K870350ESCORT EC CUSTOM IN-THE-EAR HEARING AIDHearing Tech, Inc.1987-03-11410
K854315HEARTECH MODEL IN TECHHearing Tech, Inc.1986-01-21850
K853219HEARTECH MODEL CHHearing Tech, Inc.1985-09-23530
K853218HEARTECH MODEL(HTC) (HERITAGE)Hearing Tech, Inc.1985-09-23530
K853220HEARTECH MODEL ILLUSIONHearing Tech, Inc.1985-09-23530

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