Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Telex Communications, Inc. — Predicate Candidate Screening
50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
87 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984243 | TELEX TINNITUS-COMPANION | Telex Communications, Inc. | 1999-01-21 | 55 | 0 |
| K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | Telex Communications, Inc. | 1998-10-06 | 67 | 0 |
| K964639 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSI | Telex Communications, Inc. | 1997-01-21 | 63 | 0 |
| K963915 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSI | Telex Communications, Inc. | 1996-11-08 | 39 | 0 |
| K961143 | TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 | Telex Communications, Inc. | 1996-05-07 | 47 | 0 |
| K954579 | TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION | Telex Communications, Inc. | 1995-12-08 | 67 | 0 |
| K943961 | THE MODEL ACAPPELLA IN THE EAR HEARING AID | Telex Communications, Inc. | 1995-05-15 | 273 | 0 |
| K935048 | ARTISAN PROGRAMMER & HEARING AID | Telex Communications, Inc. | 1994-02-09 | 111 | 0 |
| K935366 | BINAURAL HEARING AID | Telex Communications, Inc. | 1994-01-13 | 70 | 0 |
| K933579 | MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING | Telex Communications, Inc. | 1993-08-23 | 31 | 0 |
| K933095 | 351-AGCO BEHIND-THE-EAR HEARING AID | Telex Communications, Inc. | 1993-07-26 | 32 | 0 |
| K931157 | BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP | Telex Communications, Inc. | 1993-04-14 | 37 | 0 |
| K931158 | MEMOREX MODEL 361-AGCO HEARING AID | Telex Communications, Inc. | 1993-04-14 | 37 | 0 |
| K931134 | BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP | Telex Communications, Inc. | 1993-04-14 | 40 | 0 |
| K922065 | TELEX MODEL M29 ITE CUSTOM HEARING AID | Telex Communications, Inc. | 1992-05-18 | 14 | 0 |
| K922066 | TELEX MODEL 28A ITE CUSTOM HEARING AID | Telex Communications, Inc. | 1992-05-18 | 14 | 0 |
| K915383 | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | 1992-01-17 | 49 | 0 |
| K915384 | TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER | Telex Communications, Inc. | 1992-01-17 | 49 | 0 |
| K915397 | TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER | Telex Communications, Inc. | 1992-01-17 | 49 | 0 |
| K915398 | TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER | Telex Communications, Inc. | 1992-01-17 | 49 | 0 |
| K913495 | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC | Telex Communications, Inc. | 1991-11-01 | 87 | 0 |
| K913494 | TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC | Telex Communications, Inc. | 1991-11-01 | 87 | 0 |
| K914418 | ACT-II BEHIND THE EAR HEARING AID | Telex Communications, Inc. | 1991-10-21 | 18 | 0 |
| K912204 | TELEX MODEL TLP, IN-THE-EAR | Telex Communications, Inc. | 1991-06-20 | 31 | 0 |
| K910901 | FACEPLATE ITE HEARING AID MODEL 28A | Telex Communications, Inc. | 1991-05-30 | 86 | 0 |
| K910900 | FACEPLATE ITE HEARING AID MODEL TCA | Telex Communications, Inc. | 1991-05-30 | 86 | 0 |
| K900846 | MODEL 366 HEARING AID | Telex Communications, Inc. | 1990-05-23 | 90 | 0 |
| K870435 | MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID | Telex Communications, Inc. | 1987-03-11 | 36 | 0 |
| K870434 | MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS | Telex Communications, Inc. | 1987-03-11 | 36 | 0 |
| K860035 | MODEL 353C HEARING AID | Telex Communications, Inc. | 1986-03-17 | 70 | 0 |
| K853264 | HEARING AID MODEL 337D | Telex Communications, Inc. | 1985-09-23 | 49 | 0 |
| K853108 | MODEL 372L HEARING AID | Telex Communications, Inc. | 1985-08-22 | 30 | 0 |
| K850243 | HEARING AID 365 | Telex Communications, Inc. | 1985-03-25 | 62 | 0 |
| K844648 | MODEL 363C HEARING AID | Telex Communications, Inc. | 1985-01-07 | 39 | 0 |
| K843068 | HEARING AIDS 372 & 372 AI | Telex Communications, Inc. | 1984-12-03 | 119 | 0 |
| K843067 | TCA HEARING AID | Telex Communications, Inc. | 1984-09-05 | 30 | 0 |
| K840871 | BEHIND-THE-EAR HEARING AID 2000 | Telex Communications, Inc. | 1984-03-30 | 32 | 0 |
| K831197 | MODEL 343D HEARING AID | Telex Communications, Inc. | 1983-05-09 | 27 | 0 |
| K821132 | MODEL 28C HEAPING AID | Telex Communications, Inc. | 1982-05-13 | 23 | 0 |
| K820148 | MODEL 343 HEARING AID | Telex Communications, Inc. | 1982-02-23 | 35 | 0 |
| K792463 | MODEL 339 TELECROS WIRELESS CROS | Telex Communications, Inc. | 1980-01-09 | 37 | 0 |
| K792462 | MODEL 339 TELECROS WIRELESS BICROS | Telex Communications, Inc. | 1980-01-09 | 37 | 0 |
| K792464 | MODEL 341H (HEARING AID) | Telex Communications, Inc. | 1980-01-09 | 37 | 0 |
| K791600 | MODEL 33A HEARING AIDS | Telex Communications, Inc. | 1979-09-28 | 45 | 0 |
| K791599 | MODEL 33DA HEARING AIDS | Telex Communications, Inc. | 1979-09-28 | 45 | 0 |
| K791601 | MODEL 336A HEARING AIDS | Telex Communications, Inc. | 1979-09-28 | 45 | 0 |
| K791506 | MODEL 344 | Telex Communications, Inc. | 1979-09-19 | 47 | 0 |
| K790412 | MODEL 337E HEARING AID | Telex Communications, Inc. | 1979-03-19 | 21 | 0 |
| K790355 | MODEL 342D HEARING AIDS | Telex Communications, Inc. | 1979-03-06 | 12 | 0 |
| K790354 | MODEL 342 HEARING AIDS | Telex Communications, Inc. | 1979-03-06 | 12 | 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