Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brasseler USA I, L.P. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030172 | SMALL HIGH SPEED MOTOR DRILL SYSTEM | Brasseler USA I, L.P. | 2003-04-03 | 76 | 0 |
| K983223 | DENTAL STERLIZATION TRAY/CASSETTE | Brasseler USA I, L.P. | 1999-01-14 | 122 | 0 |
| K955140 | 2.0 X 6MM SCREW | Brasseler USA I, L.P. | 1996-01-05 | 53 | 0 |
| K945670 | KIRSCHNER (K-WIRE), STEINMAN PINS | Brasseler USA I, L.P. | 1995-03-07 | 109 | 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