Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Telesonic, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
76 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872606 | TELESONIC BODY STIMULATOR | Telesonic, Inc. | 1987-12-22 | 173 | 0 |
| K813330 | POST-AURICULAR HEARING AID MODEL S-101 | Telesonic, Inc. | 1982-01-19 | 56 | 0 |
| K813329 | POST-AURICULAR HEARING AID MODEL P-101 | Telesonic, Inc. | 1982-01-19 | 56 | 0 |
| K813316 | CUSTOM-IN-THE-EAR HEARING AID | Telesonic, Inc. | 1981-12-31 | 37 | 0 |
| K813344 | POST-AURICULAR HEARING AID MODEL ASP-103 | Telesonic, Inc. | 1981-12-31 | 36 | 0 |
| K811031 | TELESONIC & ARCON | Telesonic, Inc. | 1981-07-01 | 76 | 0 |
| K802596 | TELESONIC, ARCON & SOUNDEX ASP 102 | Telesonic, Inc. | 1980-11-12 | 22 | 0 |
| K802597 | TELESONIC ARCON & SOUNDEX ASP 101 | Telesonic, Inc. | 1980-11-12 | 22 | 0 |
| K801066 | TELESONIC, SOUNDEX & GENERIC V-101 | Telesonic, Inc. | 1980-05-28 | 22 | 0 |
| K801067 | TELESONIC, GENERIC & SOUNDEX C-102 | Telesonic, Inc. | 1980-05-28 | 22 | 0 |
| K800105 | TELESONIC (HEARING AID) | Telesonic, Inc. | 1980-02-11 | 26 | 0 |
| K792644 | TELESONIC V-101 | Telesonic, Inc. | 1980-01-23 | 28 | 0 |
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