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

Radioear Corp. — Predicate Candidate Screening

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

47 daysmedian FDA review time
91 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841934RADIOEAR M430 PPRadioear Corp.1984-09-071190
K841933RADIOEAR M420HRadioear Corp.1984-08-10910
K841475HEARING AID MODEL M400Radioear Corp.1984-06-22740
K841473HEARING AID MODEL 440PPCRadioear Corp.1984-06-22740
K841474HEARING AID MODEL P500Radioear Corp.1984-06-22740
K834523MODEL M410D HEARING AIDRadioear Corp.1984-02-10510
K811522RE-HP SERIES HEARING AIDSRadioear Corp.1981-06-26280
K800945RADIOEAR MODEL REI HEARING AIDRadioear Corp.1980-05-08160
K800567RADIOEAR MODEL RM-L & RM-C HEARING AIDRadioear Corp.1980-04-29470
K800332RADIOEAR MODEL 2080 (HEARING AID)Radioear Corp.1980-03-05200
K781458RADIOEAR RE SERIES HEARING AIDSRadioear Corp.1978-09-07150
K780667HEARING AID-MODEL 2010Radioear Corp.1978-05-03120
K770402RADIOEAR MODEL 1072Radioear Corp.1977-03-1070
K760244RADIOEAR, PERSONALRadioear Corp.1976-08-23380

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