Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MAH — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
124 daysmedian FDA review time
163 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | 2021-03-03 | 65 | 0 |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018-12-19 | 135 | 0 |
| K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | 2016-01-22 | 116 | 0 |
| K152067 | Ponto bone anchored hearing system | Oticon Medical AB | 2015-11-23 | 122 | 0 |
| K150555 | BA400 14mm Abutment | Cochlear Americas | 2015-07-15 | 133 | 0 |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bo | Oticon Medical AB | 2015-01-21 | 124 | 0 |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | Cochlear Americas | 2012-10-12 | 163 | 0 |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2012-09-07 | 137 | 0 |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2011-11-18 | 122 | 0 |
| K080363 | BAHA CORDELLE II | Cochlear Bone Anchored Systems AB | 2008-04-10 | 59 | 0 |
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIAT | Nobelpharma USA, Inc. | 1999-06-28 | 221 | 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