Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Asi Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
412 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | Asi Medical, Inc. | 2013-03-28 | 174 | 0 |
| K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED D | Asi Medical, Inc. | 2012-04-05 | 412 | 0 |
| K974488 | AIRPREP SYSTEM - MODEL 9001 | Asi Medical, Inc. | 1998-05-26 | 181 | 0 |
| K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | Asi Medical, Inc. | 1998-02-18 | 84 | 1 |
| K932873 | SEAC MOBILE UNIT BY ASI MEDICAL | Asi Medical, Inc. | 1994-03-07 | 266 | 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