Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oticon Corp. — Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
82 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963788 | PRIMOFOCUS COMPACT | Oticon Corp. | 1996-11-27 | 68 | 0 |
| K932670 | OTICON MF | Oticon Corp. | 1993-08-05 | 64 | 0 |
| K923491 | BTE HEARING AID PERSONIC 425 | Oticon Corp. | 1992-08-06 | 23 | 0 |
| K923388 | BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER | Oticon Corp. | 1992-08-06 | 30 | 0 |
| K923490 | BTE HEARING AID PERSONIC 410 | Oticon Corp. | 1992-08-06 | 22 | 0 |
| K905555 | A-ZILICONE | Oticon Corp. | 1992-07-06 | 573 | 0 |
| K904673 | OTICAON BTE MODEL E34P | Oticon Corp. | 1990-11-01 | 20 | 0 |
| K902559 | CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P | Oticon Corp. | 1990-07-09 | 28 | 0 |
| K902352 | CUSTOM ITE HEARING AID MODEL: H | Oticon Corp. | 1990-06-14 | 16 | 0 |
| K902353 | CUSTOM ITE HEARING AID MODELS F AND L | Oticon Corp. | 1990-06-14 | 16 | 0 |
| K902351 | CUSTOM ITE HEARING AID MODELS C AND M | Oticon Corp. | 1990-06-14 | 16 | 0 |
| K901292 | OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44 | Oticon Corp. | 1990-04-10 | 21 | 0 |
| K895140 | CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 | Oticon Corp. | 1989-10-11 | 56 | 0 |
| K893528 | OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID | Oticon Corp. | 1989-08-15 | 99 | 0 |
| K890703 | CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A | Oticon Corp. | 1989-03-17 | 35 | 0 |
| K890704 | BTE HEARING AID OTICON MODEL: E42P | Oticon Corp. | 1989-03-09 | 27 | 0 |
| K874651 | OTICON HEARING AID MODEL I52 | Oticon Corp. | 1988-01-19 | 67 | 0 |
| K874380 | BTE HEARING AID OTICON MODEL E38P | Oticon Corp. | 1987-12-29 | 64 | 0 |
| K874381 | BTE HEARING AID OTICON MODEL E39PL | Oticon Corp. | 1987-12-23 | 58 | 0 |
| K874744 | OTICON MODEL I50 IN-THE-EAR HEARING AID | Oticon Corp. | 1987-12-10 | 22 | 0 |
| K872372 | BEHIND-THE-EAR HEARING AID OTICON E40 | Oticon Corp. | 1987-07-31 | 42 | 0 |
| K872017 | BTE HEARING AID OTICON MODEL E30P | Oticon Corp. | 1987-06-08 | 13 | 0 |
| K862981 | OTICON I31 INITIALES HEARING AID | Oticon Corp. | 1986-10-15 | 69 | 0 |
| K862980 | OTICON I31 CITE HEARING AID | Oticon Corp. | 1986-08-26 | 19 | 0 |
| K862623 | I81 INITIALES | Oticon Corp. | 1986-08-07 | 28 | 0 |
| K862621 | I22 INITIALES | Oticon Corp. | 1986-08-01 | 22 | 0 |
| K862624 | I81 CITE | Oticon Corp. | 1986-08-01 | 22 | 0 |
| K862622 | I22 CITE | Oticon Corp. | 1986-08-01 | 22 | 0 |
| K854742 | OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE | Oticon Corp. | 1986-02-20 | 87 | 0 |
| K851429 | EARETTE HEARING AID(BEHIND THE EAR OTICON E35F | Oticon Corp. | 1985-05-29 | 49 | 0 |
| K851430 | EARETTE HEARING AID(BEHIND THE EAR OTICON E37F | Oticon Corp. | 1985-05-29 | 49 | 0 |
| K850763 | EARETTE HEARING AID OTICON E32U | Oticon Corp. | 1985-03-25 | 28 | 0 |
| K850762 | EARETTE HEARING AID OTICON MODEL E32S | Oticon Corp. | 1985-03-25 | 28 | 0 |
| K842073 | EARETTE HEARING AID OTICON E31V | Oticon Corp. | 1984-08-23 | 92 | 0 |
| K842074 | EARETTE HEARING AID OTICON E30V | Oticon Corp. | 1984-08-23 | 92 | 0 |
| K841436 | OTICON E28A | Oticon Corp. | 1984-06-27 | 82 | 0 |
| K833803 | OTICON, E26P | Oticon Corp. | 1983-12-08 | 37 | 0 |
| K821987 | EARETTE HEARING AID OPTICON MODEL E28P | Oticon Corp. | 1982-08-19 | 43 | 0 |
| K821325 | OTICON | Oticon Corp. | 1982-06-07 | 34 | 0 |
| K810986 | EARETTE HEARING AID OTICON #E25F | Oticon Corp. | 1981-05-05 | 19 | 0 |
| K810987 | EARETTE HEARING AID OTICON #E27F | Oticon Corp. | 1981-05-05 | 22 | 0 |
| K810610 | EARETTE HEARING AID OTICON #E27 | Oticon Corp. | 1981-03-20 | 14 | 0 |
| K810576 | EARETTE HEARING AID(BEHING THE EAR) | Oticon Corp. | 1981-03-17 | 14 | 0 |
| K810389 | EARETTE HEARING AID SEARS MODEL 8053 | Oticon Corp. | 1981-03-04 | 15 | 0 |
| K810379 | EARETTE HEARING AID SEARS #8054 | Oticon Corp. | 1981-03-04 | 19 | 0 |
| K801448 | OTICON MODEL E17P EARETTE HEARING AID | Oticon Corp. | 1980-07-21 | 28 | 0 |
| K801003 | OTICON EARETTE HEARING AID #E17CF | Oticon Corp. | 1980-05-28 | 30 | 0 |
| K801002 | OTICON EARETTE HEARING AID #E17 HC | Oticon Corp. | 1980-05-28 | 30 | 0 |
| K800244 | BEHIND EAR HEARING AID MODEL E24C1 | Oticon Corp. | 1980-03-19 | 43 | 0 |
| K800283 | OTICON MODEL E17VF EARETTE HEARING AID | Oticon Corp. | 1980-02-26 | 18 | 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