Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Brasamerica Medical Equipment, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983736 | ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER | Brasamerica Medical Equipment, Inc. | 1998-11-10 | 19 | 0 |
| K972371 | ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 A | Brasamerica Medical Equipment, Inc. | 1997-08-19 | 55 | 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