Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Widex Hearing Aid Co., Inc. · Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
119 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080955 | ZEN PROGRAM (MIND 440 HEARING AID) | Widex Hearing Aid Co., Inc. | 2008-06-27 | 85 | 0 |
| K971535 | WIDEX SENSO DIGITAL (MINI CANAL) | Widex Hearing Aid Co., Inc. | 1997-06-06 | 39 | 0 |
| K970904 | WIDEX SENSO DIGITAL (CIC) | Widex Hearing Aid Co., Inc. | 1997-03-26 | 14 | 0 |
| K965254 | WIDEX MODEL SENSO DIGITAL (C9) | Widex Hearing Aid Co., Inc. | 1997-03-12 | 72 | 0 |
| K965218 | SENSO DIGITAL (C18) | Widex Hearing Aid Co., Inc. | 1997-01-24 | 25 | 0 |
| K955879 | WIDEX MODEL SENSO DIGITAL (C16) | Widex Hearing Aid Co., Inc. | 1996-02-27 | 61 | 0 |
| K955878 | WIDEX MODEL SENSO DIGITAL (C8) | Widex Hearing Aid Co., Inc. | 1996-02-12 | 46 | 0 |
| K954526 | WIDEX SENSO DIGITAL (PX) | Widex Hearing Aid Co., Inc. | 1995-10-18 | 19 | 0 |
| K952229 | WIDEX MODEL LOGO 32 (L32) | Widex Hearing Aid Co., Inc. | 1995-06-19 | 38 | 0 |
| K946071 | LX-ITC | Widex Hearing Aid Co., Inc. | 1995-01-30 | 119 | 0 |
| K944518 | WIDEX MODEL LOGO 8S | Widex Hearing Aid Co., Inc. | 1994-12-27 | 102 | 0 |
| K945703 | WIDEX MODEL LOGO - L9 | Widex Hearing Aid Co., Inc. | 1994-12-23 | 51 | 0 |
| K943016 | ADOBE C.I.C | Widex Hearing Aid Co., Inc. | 1994-12-14 | 173 | 0 |
| K944097 | COMPASS SOFTWARE MODULE | Widex Hearing Aid Co., Inc. | 1994-11-15 | 85 | 0 |
| K944838 | WIDEX MODEL LX-ITE | Widex Hearing Aid Co., Inc. | 1994-10-20 | 20 | 0 |
| K943706 | AUDILENS LLK | Widex Hearing Aid Co., Inc. | 1994-08-22 | 21 | 0 |
| K941508 | WIDEX S-21 | Widex Hearing Aid Co., Inc. | 1994-05-04 | 36 | 0 |
| K935424 | WIDEX R.C. 2 (REMOTE CONTROL) | Widex Hearing Aid Co., Inc. | 1994-03-17 | 127 | 0 |
| K933644 | WIDEX MODEL LOGO 8 (L8) | Widex Hearing Aid Co., Inc. | 1993-08-23 | 27 | 0 |
| K933640 | WIDEX MODEL LOGO 12 (L12) | Widex Hearing Aid Co., Inc. | 1993-08-23 | 27 | 0 |
| K933643 | WIDEX MODEL LOGO 6 (L6) | Widex Hearing Aid Co., Inc. | 1993-08-23 | 27 | 0 |
| K931590 | ITE MODEL ADOBE 100 FULL CUSTOM | Widex Hearing Aid Co., Inc. | 1993-05-19 | 49 | 0 |
| K931591 | ITC MODEL ADOBE 100 CANAL | Widex Hearing Aid Co., Inc. | 1993-05-19 | 49 | 0 |
| K930715 | WIDEX MODEL DX HEARING AID | Widex Hearing Aid Co., Inc. | 1993-03-18 | 35 | 0 |
| K926085 | WIDEX MODEL D16 | Widex Hearing Aid Co., Inc. | 1993-02-02 | 62 | 0 |
| K926244 | WIDEX MODEL D8 (HEARING AID) | Widex Hearing Aid Co., Inc. | 1993-01-27 | 47 | 0 |
| K922708 | WIDEX MODEL D32 | Widex Hearing Aid Co., Inc. | 1992-06-30 | 25 | 0 |
| K912169 | WIDEX MODEL QX IN-THE-EAR HEARING AID | Widex Hearing Aid Co., Inc. | 1991-05-28 | 12 | 0 |
| K901642 | WIDEX HEARING AID MODEL THE DISCOVERY | Widex Hearing Aid Co., Inc. | 1990-05-23 | 44 | 0 |
| K897033 | WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE | Widex Hearing Aid Co., Inc. | 1990-05-23 | 156 | 0 |
| K901317 | WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL | Widex Hearing Aid Co., Inc. | 1990-04-10 | 20 | 0 |
| K901316 | WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL | Widex Hearing Aid Co., Inc. | 1990-04-10 | 20 | 0 |
| K895982 | WIDEX HEARING AID MODEL ES 10 ASP T | Widex Hearing Aid Co., Inc. | 1990-03-15 | 154 | 0 |
| K895981 | WIDEX HEARING AID MODELS ES9T AND ES9H | Widex Hearing Aid Co., Inc. | 1990-03-15 | 154 | 0 |
| K885128 | WIDEX BTE HEARING AID MODEL Q8 | Widex Hearing Aid Co., Inc. | 1989-03-01 | 79 | 0 |
| K884113 | HEARING AID WIDEX BTE | Widex Hearing Aid Co., Inc. | 1988-12-19 | 81 | 0 |
| K880273 | WIDEX HEARING AID MODEL C1 | Widex Hearing Aid Co., Inc. | 1988-03-14 | 52 | 0 |
| K872374 | WIDEX HEARING AID MODEL ES1 | Widex Hearing Aid Co., Inc. | 1987-07-31 | 42 | 0 |
| K872375 | WIDEX HEARING AID MODEL ES6 | Widex Hearing Aid Co., Inc. | 1987-07-28 | 39 | 0 |
| K864097 | WIDEX HEARING AID MODEL ES2 | Widex Hearing Aid Co., Inc. | 1986-11-05 | 15 | 0 |
| K853793 | WIDEX MODEL M1 | Widex Hearing Aid Co., Inc. | 1985-12-02 | 82 | 0 |
| K832376 | WIDEX HEARING AID MODEL L1 | Widex Hearing Aid Co., Inc. | 1983-09-29 | 73 | 0 |
| K832129 | HEARING AID G3H & G3T | Widex Hearing Aid Co., Inc. | 1983-07-26 | 25 | 0 |
| K830465 | WIDEX HEARING AID #G2H & G2T | Widex Hearing Aid Co., Inc. | 1983-05-09 | 83 | 0 |
| K823460 | MODELS G6H, G6T, G1H & G1T | Widex Hearing Aid Co., Inc. | 1982-12-03 | 14 | 0 |
| K823431 | HEARING AID #G6H & G6T | Widex Hearing Aid Co., Inc. | 1982-12-03 | 17 | 0 |
| K792567 | WIDEX HEARING AID MODEL 820 | Widex Hearing Aid Co., Inc. | 1980-01-23 | 58 | 0 |
| K792389 | WIDEX HEARING AID MODEL S10 | Widex Hearing Aid Co., Inc. | 1980-01-23 | 58 | 0 |
| K770688 | HEARING AID MODEL F8H ANL F8T | Widex Hearing Aid Co., Inc. | 1977-04-20 | 7 | 0 |
| K770689 | HEARING AID MODEL A8H AND A8T | Widex Hearing Aid Co., Inc. | 1977-04-20 | 7 | 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