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

Telstar Electronics, Inc. — Predicate Candidate Screening

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

49 daysmedian FDA review time
57 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892460TELSTAR MODEL PP ITE HEARING AIDTelstar Electronics, Inc.1989-06-06570
K892457TELSTAR MODEL 1/3 ITE HEARING AIDTelstar Electronics, Inc.1989-06-06570
K892459TELSTAR MODEL C ITE HEARING AIDTelstar Electronics, Inc.1989-06-06570
K892458TELSTAR MODEL F ITE HEARING AIDTelstar Electronics, Inc.1989-06-06570
K871731TELSTAR PREWIRE SERIESTelstar Electronics, Inc.1987-10-271750
K873210TELSTAR MODEL PPTelstar Electronics, Inc.1987-09-29460
K871520TELSTAR MODEL FS HEARING AIDTelstar Electronics, Inc.1987-06-08490
K871522TELSTAR MODEL C HEARING AIDTelstar Electronics, Inc.1987-06-05460
K871518TELSTAR MODEL F3TS HEARING AIDTelstar Electronics, Inc.1987-06-05460
K871521FULL SHELL ITE HEARING AIDTelstar Electronics, Inc.1987-06-05460
K871519TELSTAR MODEL 0/3 HEARING AIDTelstar Electronics, Inc.1987-05-19290

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