Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Braebon Medical Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
189 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061764 | MEDIBYTE, MODEL MP8 | Braebon Medical Corp. | 2006-09-06 | 76 | 0 |
| K031202 | MEDIPALM-20 | Braebon Medical Corp. | 2003-05-01 | 15 | 0 |
| K020312 | ULTIMA SNORING MIKE, MODEL 0540 | Braebon Medical Corp. | 2002-08-07 | 189 | 0 |
| K001743 | ULTIMA SMARTBELT, MODEL 0560 | Braebon Medical Corp. | 2000-08-25 | 78 | 0 |
| K984431 | ULTIMA AIRFLOW PRESSURE SENSOR | Braebon Medical Corp. | 1998-12-30 | 19 | 0 |
| K981445 | ULTIMA AIRFLOW SENSOR, 0510 | Braebon Medical Corp. | 1998-10-05 | 166 | 0 |
| K982216 | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 | Braebon Medical Corp. | 1998-09-11 | 80 | 0 |
| K981969 | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | 1998-08-20 | 77 | 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