Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smartpractice — 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) |
|---|---|---|---|---|---|
| K123184 | FINN CHAMBERS AQUA | Smartpractice | 2012-12-19 | 70 | 0 |
| K103409 | ALLERGEAZE R CLEAR | Smartpractice | 2011-03-15 | 113 | 0 |
| K063160 | ALLERGEAZE PATCH TEST CHAMBERS | Smartpractice | 2006-12-22 | 66 | 0 |
| K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | 2002-12-11 | 75 | 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