Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Midwest — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
36 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821895 | AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR | American Midwest | 1982-07-16 | 18 | 0 |
| K821715 | AM-40 SYSTEM | American Midwest | 1982-06-25 | 15 | 0 |
| K820693 | MIDWEST LIGHT WAND | American Midwest | 1982-04-09 | 28 | 0 |
| K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS | American Midwest | 1981-08-18 | 36 | 0 |
| K800735 | U-STYLE ADAPTER | American Midwest | 1980-04-10 | 8 | 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