Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Braemar, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
72 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081444 | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORI | Braemar, Inc. | 2008-07-31 | 70 | 0 |
| K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER | Braemar, Inc. | 2007-10-03 | 72 | 2 |
| K071733 | DL900 SERIES HOLTER RECORDER | Braemar, Inc. | 2007-07-24 | 28 | 0 |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG | Braemar, Inc. | 2007-04-27 | 17 | 0 |
| K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | Braemar, Inc. | 2004-10-06 | 23 | 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