Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Entific Medical Systems, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| 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 |
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