Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LXB — Predicate Candidate Screening
52 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
214 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254296 | Ossiclear (Ossiclear System) | Sounduct | 2026-07-22 | 203 | 0 |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 | 124 | 0 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-A | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 | 56 | 0 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); | Cochlear | 2025-05-29 | 125 | 0 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 | 210 | 0 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 | 20 | 0 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Co | Cochlear Americas | 2021-09-29 | 83 | 0 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 | 75 | 0 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting S | Cochlear Americas | 2021-02-23 | 214 | 0 |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 | 59 | 0 |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 | 256 | 0 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 | 56 | 0 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016-09-29 | 105 | 0 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Co | Sophono, Inc. | 2016-06-16 | 205 | 0 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 | 29 | 0 |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016-03-02 | 114 | 0 |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015-07-22 | 121 | 0 |
| K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015-03-25 | 170 | 0 |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Oticon Medical AB | 2013-12-09 | 95 | 0 |
| K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM | Sophono, Inc. | 2013-11-22 | 130 | 0 |
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | Cochlear Americas | 2013-11-07 | 190 | 1 |
| K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR | Cochlear Americas | 2013-09-26 | 65 | 0 |
| K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2013-04-08 | 103 | 0 |
| K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | Audifon-USA, Inc. | 2012-11-01 | 135 | 0 |
| K110831 | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL | Sonitus Medical, Inc. | 2011-06-21 | 88 | 5 |
| K103594 | PONTO PRO POWER | Oticon Medical AB | 2011-06-15 | 189 | 0 |
| K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND | Sophono, Inc. | 2011-05-23 | 292 | 0 |
| K110996 | BAHA 3 POWER SOUND PROCESSOR | Cochlear Americas | 2011-05-10 | 29 | 0 |
| K100649 | SOUNDBITE HEARING SYSTEM BY SONITUS | Sonitus Medical, Inc. | 2011-01-14 | 312 | 0 |
| K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABU | Cochlear Americas | 2010-07-13 | 151 | 0 |
| K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2010-05-18 | 116 | 0 |
| K090996 | PONTO PRO | Oticon Medical AB | 2009-07-29 | 112 | 0 |
| K090720 | COCHLEAR BAHA BP100 | Cochlear Bone Anchored Systems AB | 2009-06-17 | 91 | 0 |
| K082108 | OBC BONE ANCHORED HEARING AID SYSTEM | Oticon Medical AB | 2008-11-14 | 112 | 0 |
| K081606 | BAHA INTENSO | Cochlear Americas | 2008-08-28 | 83 | 0 |
| K062404 | TRANSEAR BONE CONDUCTION HEARING AID | Ear Technology Corp. | 2006-09-08 | 22 | 0 |
| K050653 | TRANSEAR BONE CONDUCTION HEARING AID | United Hearing Systems, Inc. | 2005-07-01 | 112 | 0 |
| K042017 | BAHA DIVINO | Entific Medical Systems, Inc. | 2004-08-26 | 30 | 0 |
| K021837 | BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) | Entific Medical Systems, Inc. | 2002-08-30 | 87 | 0 |
| K011438 | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID | Entific Medical Systems, Inc. | 2001-07-23 | 74 | 0 |
| K002913 | HEADBAND FOR BAHA | Entific Medical Systems, Inc. | 2000-10-17 | 29 | 0 |
| K992872 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II | Entific Medical Systems, Inc. | 1999-11-24 | 90 | 0 |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | Nobelpharma USA, Inc. | 1996-08-09 | 235 | 0 |
| K953872 | SECOND EAR BONE CONDUCTION HEARING AID | Wordcomp International Communication Group (Wicg) | 1996-04-12 | 239 | 0 |
| K951678 | HI SONIC 2000 DIGITAL HEARING INSTRUMENT | Hearing Innovations, Inc. | 1995-06-07 | 57 | 0 |
| K935701 | VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 | Starkey Laboratories, Inc. | 1994-05-10 | 161 | 0 |
| K884056 | MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR | Xomed, Inc. | 1988-11-30 | 65 | 0 |
| K881382 | XOMED AUDIANT BONE CONDUCTOR | Xomed, Inc. | 1988-06-21 | 81 | 0 |
| K875277 | ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. | Xomed, Inc. | 1988-03-14 | 81 | 0 |
| K872168 | XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. | Xomed, Inc. | 1987-06-30 | 22 | 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