Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beltone Electronics Corp. — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
121 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971852 | AIR CONDUCTION HAEARING AIDS | Beltone Electronics Corp. | 1997-08-15 | 87 | 0 |
| K963958 | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT | Beltone Electronics Corp. | 1996-12-05 | 64 | 0 |
| K955930 | BELTONE COMPOSER 2000 BTE HP | Beltone Electronics Corp. | 1996-03-01 | 71 | 0 |
| K954936 | BELTONE ULTIMA 80 OTOSONIC POWER PAS | Beltone Electronics Corp. | 1995-12-06 | 40 | 0 |
| K943616 | BELTONE PERSONAL HEARING SCREENER | Beltone Electronics Corp. | 1995-07-12 | 350 | 0 |
| K951587 | BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K | Beltone Electronics Corp. | 1995-06-30 | 85 | 0 |
| K950868 | BELTONE COMPOSER 2000 | Beltone Electronics Corp. | 1995-06-28 | 121 | 0 |
| K952097 | OTOSONIC (OSI) CF 10-K, 10-D | Beltone Electronics Corp. | 1995-06-28 | 55 | 0 |
| K946340 | BELTONE COMPARAFIT | Beltone Electronics Corp. | 1995-04-13 | 105 | 0 |
| K944502 | BELTONE CONCERTO S | Beltone Electronics Corp. | 1994-10-20 | 36 | 0 |
| K942716 | AUDIO EXPERT AUDIOMETER | Beltone Electronics Corp. | 1994-09-02 | 85 | 0 |
| K940216 | BELTONE SERIES 100 AUDIOMETERS | Beltone Electronics Corp. | 1994-07-29 | 196 | 0 |
| K942213 | OPTIMA WITH DELTA AMP | Beltone Electronics Corp. | 1994-06-17 | 42 | 0 |
| K940098 | BELTONE INVISA | Beltone Electronics Corp. | 1994-06-15 | 156 | 0 |
| K941395 | BELTON MERIT (HEARING AID) | Beltone Electronics Corp. | 1994-05-04 | 43 | 0 |
| K940100 | PROFILE IC; PROFILE CLEARVOICE; PROFILE | Beltone Electronics Corp. | 1994-04-01 | 81 | 0 |
| K940102 | BELTONE OPERA/OPERA MHP/OPERA MAX | Beltone Electronics Corp. | 1994-04-01 | 81 | 0 |
| K940103 | BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTON | Beltone Electronics Corp. | 1994-04-01 | 81 | 0 |
| K940099 | OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP | Beltone Electronics Corp. | 1994-04-01 | 81 | 0 |
| K940101 | OTOSONIC ACS II D WITH SRR | Beltone Electronics Corp. | 1994-04-01 | 81 | 0 |
| K940177 | OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D | Beltone Electronics Corp. | 1994-04-01 | 80 | 0 |
| K940104 | OTOSONIC MINI PAS | Beltone Electronics Corp. | 1994-03-24 | 73 | 0 |
| K934618 | OTOSONIC ADVANCED FULL SHIELD (AFS) | Beltone Electronics Corp. | 1993-11-19 | 53 | 0 |
| K932703 | BELTONE PRIMA 2000 | Beltone Electronics Corp. | 1993-08-19 | 77 | 0 |
| K932426 | BELTONE OPERA/OPERA MHP/OPERA MAX | Beltone Electronics Corp. | 1993-07-14 | 56 | 0 |
| K931881 | IN THE CANAL AID OTOSONIC ACS II WITH SRR | Beltone Electronics Corp. | 1993-07-02 | 79 | 0 |
| K932058 | BELTONE OPTIMA 2000 ITE HEARING AID | Beltone Electronics Corp. | 1993-07-02 | 65 | 0 |
| K930598 | OTOSONIC FSD, IN-THE-EAR HEARING AID | Beltone Electronics Corp. | 1993-03-18 | 41 | 0 |
| K930318 | BELTONE OPERA LOR, ITC | Beltone Electronics Corp. | 1993-03-01 | 38 | 0 |
| K930310 | BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR | Beltone Electronics Corp. | 1993-03-01 | 38 | 0 |
| K922827 | OTOSONIC ACS K | Beltone Electronics Corp. | 1992-07-01 | 19 | 0 |
| K922301 | BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) | Beltone Electronics Corp. | 1992-06-10 | 26 | 0 |
| K922224 | OTOSONIC ACS-IC | Beltone Electronics Corp. | 1992-05-27 | 15 | 0 |
| K915323 | THE BELTONE AUDIO SCOUT | Beltone Electronics Corp. | 1992-05-11 | 171 | 0 |
| K921023 | BELTONE OPRA CLEAR VOICE-K HEARING AID | Beltone Electronics Corp. | 1992-03-19 | 16 | 0 |
| K914981 | OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID | Beltone Electronics Corp. | 1991-11-27 | 21 | 0 |
| K914982 | BELTONE PROFILE IN-THE-EAR HEARING AID | Beltone Electronics Corp. | 1991-11-27 | 21 | 0 |
| K914939 | OTOSONIC ACS-ASP | Beltone Electronics Corp. | 1991-11-22 | 18 | 0 |
| K914940 | BELTONE CLEARVOICE | Beltone Electronics Corp. | 1991-11-22 | 18 | 0 |
| K875360 | THE BELTONE 2000 AUDIOMETER | Beltone Electronics Corp. | 1988-02-17 | 48 | 0 |
| K854001 | CERTI-FORM | Beltone Electronics Corp. | 1985-12-31 | 92 | 0 |
| K800784 | MINUET MASKER; JUBILEE MASKER | Beltone Electronics Corp. | 1980-04-29 | 21 | 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