Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Braemar Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
175 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030856 | ER800 SERIES ECG EVENT RECORDER | Braemar Corp. | 2003-03-28 | 10 | 0 |
| K993617 | DIGITRAKPLUS HOLTER RECORDER | Braemar Corp. | 1999-11-24 | 29 | 0 |
| K993618 | DXP1000 HOLTER RECORDER | Braemar Corp. | 1999-11-24 | 29 | 0 |
| K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER7 | Braemar Corp. | 1998-09-28 | 164 | 0 |
| K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER | Braemar Corp. | 1995-04-12 | 175 | 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